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Philips Medical Systems Nederland B.V.: FDA-registered device maker in Eindhoven Noord-Brabant, Netherlands, 12 510(k) clearances

Name: Philips Medical Systems Nederland B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips Medical Systems Nederland B.V. is registered with the FDA (registration 3000976525) in Eindhoven Noord-Brabant, Netherlands. It lists 8 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 2, 2025. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3000976525
Address: High Tech Campus 36, Eindhoven Noord-Brabant, Netherlands, 5656 AE
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Complaint file establishment, Exporter to the US, Manufacturer
First device listed: September 3, 2009
Registered through: 2026
Brand names listed: AutoQuant, CAAS workstation, CSMC Cardiac Suite, IntelliSpace Cardiovascular, Philips Hemodynamic Application R1, QLAB Advanced Quantification Software, TOMTEC-ARENA, Ultrasound Workspace and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Exporter to the US	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 2, 2025	K251215	Philips IntelliSpace Cardiovascular	LLZ	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
February 10, 2025	K241659	Ultrasound Workspace (UWS 6.0)	QIH	Substantially Equivalent	Philips Ultrasound, LLC	accessdata.fda.gov
June 3, 2022	K211046	eCareManager 4.5	MSX	Substantially Equivalent	Visicu, Inc.	accessdata.fda.gov
January 6, 2022	K213544	TOMTEC-ARENA	QIH	Substantially Equivalent	Tomtec Imaging Systems GmbH	accessdata.fda.gov
June 3, 2020	K200974	QLAB Advanced Quantification Software	QIH	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
September 7, 2018	K181311	Philips Hemodynamic Application R1.0	MWI	Substantially Equivalent	Philips Medical Systems Nederlands B.V.	accessdata.fda.gov
May 3, 2018	K180019	CAAS Workstation	IZI	Substantially Equivalent	Pie Medical Imaging BV	accessdata.fda.gov
November 3, 2017	K172609	CSMC Cardiac Suite	KPS	Substantially Equivalent	Cedars-Sinai Medical Center	accessdata.fda.gov
November 18, 2015	K153022	Philips IntelliSpace Cardiovascular	LLZ	Substantially Equivalent	Philips Medical Systems Nethrlands BV	accessdata.fda.gov
July 22, 2014	K141652	CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE	KPS	Substantially Equivalent	Cedars-Sinai Medical Center	accessdata.fda.gov
October 26, 2010	K101571	XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS	MWI	Substantially Equivalent	Witt Biomedical Corp	accessdata.fda.gov
September 6, 2006	K061995	XCELERA	LLZ	Substantially Equivalent	Philips Medical Systems North America Co.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 8, 2025	97379	Class II	Ongoing	IntelliSpace Cardiovascular, Software 8.0.0.4.	Software issue that results in the display of outdated information.	accessdata.fda.gov
April 7, 2025	96377	Class II	Ongoing	IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.	An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.	accessdata.fda.gov
April 4, 2024	96129	Class II	Ongoing	Philips IntelliSpace Cardiovascular software, Model 830089.	Study data is not able to be archived, copied, or exported with the cardiovascular software version.	accessdata.fda.gov
July 20, 2023	96598	Class II	Ongoing	Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.	Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.	accessdata.fda.gov
July 19, 2023	92855	Class II	Ongoing	Allura Xper series	A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation	accessdata.fda.gov

Compare with other makers

Updated October 2, 2025. 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.