Data / Medical devices / Netherlands / DHL Supply Chain (netherlands) B.V.

DHL Supply Chain (netherlands) B.V.: FDA-registered device maker in Beringe Limburg, Netherlands, 172 510(k) clearances

Name: DHL Supply Chain (netherlands) B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DHL Supply Chain (netherlands) B.V. is registered with the FDA (registration 3009077524) in Beringe Limburg, Netherlands. It lists 94 device types. The FDA files 172 510(k) clearances under its listings, the newest dated December 23, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009077524
Address: Zwenkgras 9, Beringe Limburg, Netherlands, 5986 PM
Owner or operator: DHL Supply Chain (Netherlands) B.V. (10085309)
Roles: Exporter to the US
First device listed: June 2, 2022
Registered through: 2026
Brand names listed: 1.5T 16-CHANNEL HAND-WRIST COIL, 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484, 1.5T AND 3T GENERAL PURPOSE FLEX COILS, 1.5T and 3T 16 CH GE Shoulder Coils, 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL, ACHIEVA 1.5T & INERA 1.5T FAMILY, ACHIEVA, INTERA AND PANORAMA 1T, RELEASE 2.5, ALLTECH ECHOSTAR 1.5 T MR SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Exporter to the US	accessdata.fda.gov
Adaptor, Lead Switching, Electrocardiograph	DRW	2	Exporter to the US	accessdata.fda.gov
Aid, Cardiopulmonary Resuscitation	LIX	2	Exporter to the US	accessdata.fda.gov
Alarm, Blood-Pressure	DSJ	2	Exporter to the US	accessdata.fda.gov
Amplifier And Signal Conditioner, Transducer Signal	DRQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Exporter to the US	accessdata.fda.gov
Analyzer, Spectrum, Electroencephalogram Signal	GWS	1	Exporter to the US	accessdata.fda.gov
Automated External Defibrillators (Non-Wearable)	MKJ	3	Exporter to the US	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Exporter to the US	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Exporter to the US	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Exporter to the US	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Exporter to the US	accessdata.fda.gov
Cable, Electrode	IKD	2	Exporter to the US	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Exporter to the US	accessdata.fda.gov
Calculator, Pulmonary Function Data	BZC	2	Exporter to the US	accessdata.fda.gov
Cassette, Radiographic Film	IXA	2	Exporter to the US	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Exporter to the US	accessdata.fda.gov
Coil, Magnetic Resonance, Specialty	MOS	2	Exporter to the US	accessdata.fda.gov
Collimator, Automatic, Radiographic	IZW	2	Exporter to the US	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Exporter to the US	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US	accessdata.fda.gov
Continuous, Ventilator, Home Use	NOU	2	Exporter to the US	accessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)	LDD	2	Exporter to the US	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Exporter to the US	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Exporter to the US	accessdata.fda.gov
Electrocardiograph	DPS	2	Exporter to the US	accessdata.fda.gov
Electrocardiograph, Ambulatory (Without Analysis)	MWJ	2	Exporter to the US	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Exporter to the US	accessdata.fda.gov
Generator, Electroencephalograph Test Signal	GWR	1	Exporter to the US	accessdata.fda.gov
Grid, Radiographic	IXJ	1	Exporter to the US	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Exporter to the US	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Exporter to the US	accessdata.fda.gov
Holder, Head, Neurosurgical (Skull Clamp)	HBL	2	Exporter to the US	accessdata.fda.gov
Incubator, Neonatal	FMZ	2	Exporter to the US	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Exporter to the US	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Exporter to the US	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Exporter to the US	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Exporter to the US	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Exporter to the US	accessdata.fda.gov
Monitor, Carbon-Dioxide, Cutaneous	LKD	2	Exporter to the US	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Exporter to the US	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	KLK	2	Exporter to the US	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	LPP	2	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Exporter to the US	accessdata.fda.gov
Monitor, St Segment	MLC	2	Exporter to the US	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Exporter to the US	accessdata.fda.gov
Monitor, Uterine Contraction, External (For Use In Clinic)	HFM	2	Exporter to the US	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Exporter to the US	accessdata.fda.gov
Over-The-Counter Automated External Defibrillator	NSA	3	Exporter to the US	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	DRO	2	Exporter to the US	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Exporter to the US	accessdata.fda.gov
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	JOM	2	Exporter to the US	accessdata.fda.gov
Probe, Thermodilution	KRB	2	Exporter to the US	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Exporter to the US	accessdata.fda.gov
Recorder, Paper Chart	DSF	1	Exporter to the US	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Exporter to the US	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Exporter to the US	accessdata.fda.gov
Strip, Test Isoniazid	MIG	U	Exporter to the US	accessdata.fda.gov
System, Balloon, Intra-Aortic And Control	DSP	2	Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Exporter to the US	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	accessdata.fda.gov
System, Monitoring, Perinatal	HGM	2	Exporter to the US	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Exporter to the US	accessdata.fda.gov
System, Planning, Radiation Therapy Treatment	MUJ	2	Exporter to the US	accessdata.fda.gov
System, Signal Isolation	DRJ	1	Exporter to the US	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Exporter to the US	accessdata.fda.gov
Table, Radiographic, Tilting	IXR	2	Exporter to the US	accessdata.fda.gov
Tester, Electrode, Surface, Electrocardiographic	KRC	2	Exporter to the US	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Exporter to the US	accessdata.fda.gov
Transducer, Pressure, Intrauterine	HFN	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Obstetric	HGL	2	Exporter to the US	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Exporter to the US	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 172.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 23, 2021	K213766	dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
December 1, 2021	K212864	dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T	MOS	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
October 29, 2021	K213351	ds Head 32ch 3.0T	MOS	Substantially Equivalent	Invivo Corporation (Business Trade Name: Philips)	accessdata.fda.gov
September 24, 2021	K212704	Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
December 3, 2020	K203087	CombiDiagnost R90	JAA	Substantially Equivalent	Philips Medical Systems Dmc GmbH	accessdata.fda.gov
September 30, 2020	K202564	DigitalDiagnost C90	MQB	Substantially Equivalent	Philips Medical Systems Dmc GmbH	accessdata.fda.gov
September 2, 2020	K202216	EPIQ Series Diagnostic Ultrasound Systems	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
June 2, 2020	K193438	DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)	HBL	Substantially Equivalent	Pro Med Instruments GmbH	accessdata.fda.gov
May 14, 2020	K201053	PercuNav Image Fusion and Interventional Navigation	JAK	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
May 1, 2020	K201012	EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
March 6, 2020	K200304	EPIQ Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
September 6, 2019	K192226	Lumify Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
August 2, 2019	K191813	MobileDiagnost wDR 2.2	IZL	Substantially Equivalent	Sedecal., Sa.	accessdata.fda.gov
July 18, 2019	K181166	Trilogy Evo	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
June 4, 2019	K190461	Achieva 1.5T, 3.0T and Intera 1.5T MR Systems	LNH	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
February 14, 2019	K183063	Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems	LNH	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
November 9, 2018	K182857	EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
October 23, 2018	K182529	Xperius Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
July 27, 2018	K181485	EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
March 21, 2018	K163661	P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil	MOS	Substantially Equivalent	Rapid Biomedical GmbH	accessdata.fda.gov
February 5, 2018	K173433	ProxiDiagnost N90	OWB	Substantially Equivalent	Philips Medical Systems Dmc GmbH	accessdata.fda.gov
December 13, 2017	K172056	InnoSight Diagnostic Ultrasound System	IYO	Substantially Equivalent	Qisda Corporation	accessdata.fda.gov
October 4, 2017	K172607	Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
February 9, 2017	K170086	Pinnacle Radiation Therapy Planning System	MUJ	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
January 31, 2017	K163210	Philips CombiDiagnost R90	JAA	Substantially Equivalent	Philips Medical Systems Dmc GmbH	accessdata.fda.gov
January 10, 2017	K163120	EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
January 6, 2017	K163116	Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3	LNH	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
November 7, 2016	K162863	dS Small Extremity 16CH 1.5T Coil	MOS	Substantially Equivalent	Invivo Therapeutics Corporation	accessdata.fda.gov
October 3, 2016	K162549	Lumify Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
September 14, 2016	K162329	CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
September 14, 2016	K162177	dS FootAnkle I6CH 1.5T Coil	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
August 31, 2016	K162001	1.5T and 3.0T 16 CH GE Shoulder Coils	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
April 6, 2016	K160807	EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
December 23, 2015	K152330	Expression MR400 MRI Patient Monitoring System	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
December 16, 2015	K153480	ClearVue850 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
October 30, 2015	K152899	Philips Lumify Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Healthcare, Inc.	accessdata.fda.gov
July 31, 2015	K151904	SyncVision System	OWB	Substantially Equivalent	Volcano Corporation	accessdata.fda.gov
July 17, 2015	K151681	IntelliVue Patient Monitor	DSI	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
May 13, 2015	K150310	IntelliVue Patient Monitor	DSI	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
November 25, 2014	K140535	PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50	HGM	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH	accessdata.fda.gov
July 25, 2014	K141736	PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST	MQB	Substantially Equivalent	Philips Medical Systems Dmc GmbH	accessdata.fda.gov
July 2, 2014	K141369	VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
June 26, 2014	K133961	SURESIGNS VS3, SURESIGNS VS4	DSJ	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
June 12, 2014	K141381	DURADIAGNOST	KPR	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
October 18, 2013	K130684	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
August 21, 2013	K132304	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
July 15, 2013	K131382	EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
May 20, 2013	K130457	3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL	MOS	Substantially Equivalent	Resonance Innovations, LLC	accessdata.fda.gov
March 12, 2013	K130153	HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST	MKJ	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
February 22, 2013	K124061	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
December 21, 2012	K123754	CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
December 21, 2012	K122897	SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
December 13, 2012	K123492	DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)	MOS	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
November 2, 2012	K122646	DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
August 29, 2012	K122439	INTELLIVUE PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
May 1, 2012	K113145	ECHELON OVAL MRI SYSTEM	LNH	Substantially Equivalent	Hitachi Medical Systems America, Inc.	accessdata.fda.gov
February 17, 2012	K120321	CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
February 10, 2012	K120122	SENSE MSK S 8CH 1.5T	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
December 23, 2011	K111673	1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
October 28, 2011	K111693	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
September 30, 2011	K110474	PHILIPS INTELLIVUE TCG10	LKD	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
August 25, 2011	K112112	SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS	MOS	Substantially Equivalent	Sentinel Medical, Inc.	accessdata.fda.gov
August 18, 2011	K103274	SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING	MOS	Substantially Equivalent	Sentinelle Medical, Inc.	accessdata.fda.gov
August 17, 2011	K111083	PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50	HGM	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
June 24, 2011	K111513	CX50 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
March 31, 2011	K110622	INTELLIVUE PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
March 15, 2011	K103700	ESSENTIAL MRI PATIENT MONITOR	DQA	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
January 7, 2011	K103646	INTELLIVUE MX40 PATIENT MONITOR	MHX	Substantially Equivalent	Phillips Medical Systems	accessdata.fda.gov
January 3, 2011	K103149	1.5T 16-CHANNEL HAND-WRIST COIL	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
October 26, 2010	K101571	XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS	MWI	Substantially Equivalent	Witt Biomedical Corp	accessdata.fda.gov
July 28, 2010	K101949	PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601	MOS	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.	accessdata.fda.gov
July 14, 2010	K101858	PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701	MOS	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.	accessdata.fda.gov
May 11, 2010	K093268	INTELLIVUE PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
April 22, 2010	K100113	VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51	MOS	Substantially Equivalent	Sentinelle Medical, Inc.	accessdata.fda.gov
March 5, 2010	K093842	1.5T AND 3.0T GENERAL PURPOSE FLEX COILS	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
February 17, 2010	K092028	PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50	HGM	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
February 1, 2010	K093563	IU22 ULTRASOUND SYSTEM AND TRANSDUCERS	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
January 19, 2010	K093693	NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH	MOS	Substantially Equivalent	Noras Mri Products GmbH	accessdata.fda.gov
December 15, 2009	K090785	MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214	MWI	Substantially Equivalent	Invivo Corp.	accessdata.fda.gov
August 21, 2009	K091902	1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484	MOS	Substantially Equivalent	Invivo	accessdata.fda.gov
July 17, 2009	K091804	CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS	ITX	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
July 14, 2009	K091517	RALCO, MODEL R225 ACS	IZW	Substantially Equivalent	Ralco S.R.L.	accessdata.fda.gov
November 6, 2008	K082987	HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL	MOS	Substantially Equivalent	Invivo	accessdata.fda.gov
October 15, 2008	K082916	HRB-127-32 HIGH RESOLUTION BRAIN COIL	MOS	Substantially Equivalent	Invivo	accessdata.fda.gov
August 6, 2008	K082100	ALLTECH ECHOSTAR 1.5 T MR SYSTEM	LNH	Substantially Equivalent	Alltech Medical Systems America, Inc.	accessdata.fda.gov
June 24, 2008	K081661	HD15 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
June 18, 2008	K081340	PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201	MOS	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.	accessdata.fda.gov
June 18, 2008	K081322	MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL	MOS	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.	accessdata.fda.gov
May 9, 2008	K080999	PAGEWRITER CARDIOGRAPH	DPS	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
March 27, 2008	K080548	HD7 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Phillips Medical Systems	accessdata.fda.gov
January 22, 2008	K080038	VANTAGE TITAN, MODEL MRT-1504/S3	LNH	Substantially Equivalent	Toshiba America Medical Systems, In.C	accessdata.fda.gov
November 26, 2007	K072780	MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR	IZW	Substantially Equivalent	Ralco S.R.L.	accessdata.fda.gov
November 20, 2007	K072286	BIS EEG VISTA MONITOR SYSTEM AND BISX	OLW	Substantially Equivalent	Aspect Medical Systems, Inc.	accessdata.fda.gov
November 16, 2007	K072873	LBS-63-16 BREAST ARRAY COIL	MOS	Substantially Equivalent	Invivo	accessdata.fda.gov
July 24, 2007	K071733	DL900 SERIES HOLTER RECORDER	MWJ	Substantially Equivalent	Braemar, Inc.	accessdata.fda.gov
May 22, 2007	K070920	FUJI IP CASSETTE TYPE PC	IYE	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.	accessdata.fda.gov
February 8, 2007	K063725	MP5 INTELLIVUE PATIENT MONITOR	MHX	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	accessdata.fda.gov
January 4, 2007	K063559	ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5	LNH	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
December 14, 2006	K063580	SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Medison Co., Ltd.	accessdata.fda.gov
October 13, 2006	K062767	CTL-63 AND CTL-128 SPINE ARRAY COILS	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov

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Updated December 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.