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Makar Consulting Pty Ltd: FDA-registered device maker in Belrose New South Wales, Australia, 60 510(k) clearances and 3 PMA approvals

Name: Makar Consulting Pty Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Makar Consulting Pty Ltd is registered with the FDA (registration 3010703925) in Belrose New South Wales, Australia. It lists 44 device types. The FDA files 60 510(k) clearances and 3 PMA approvals under its listings, the newest dated August 7, 2026. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3010703925
Address: 1 Garigal Road, Belrose New South Wales, Australia, 2085
Owner or operator: Makar Consulting Pty Ltd (10062928)
Roles: Exporter to the US
First device listed: March 13, 2020
Registered through: 2027
Brand names listed: Affiniti 70, Datex-Ohmeda, Definition Edge, Epiq Ultrasounds, GE CT Scanner, GE Healthcare, GE Logiq Fortis, GE Logiq P8 and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Lead Switching, Electrocardiograph	DRW	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Assembly, Tube Housing, X-Ray, Diagnostic	ITY	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
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	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
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Exporter to the US	accessdata.fda.gov
Compressor, Cardiac, External	DRM	2	Exporter to the US	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Exporter to the US	accessdata.fda.gov
Console, Heart-Lung Machine, Cardiopulmonary Bypass	DTQ	2	Exporter to the US	accessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)	LDD	2	Exporter to the US	accessdata.fda.gov
Densitometer, Bone	KGI	2	Exporter to the US	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Exporter to the US	accessdata.fda.gov
Digital Breast Tomosynthesis	OTE	3	Exporter to the US	accessdata.fda.gov
Endoscope, Accessories, Image Post-Processing For Color Enhancement	PEA	2	Exporter to the US	accessdata.fda.gov
Endoscope, Accessories, Narrow Band Spectrum	NWB	2	Exporter to the US	accessdata.fda.gov
Full Field Digital, System, X-Ray, Mammographic	MUE	2	Exporter to the US	accessdata.fda.gov
Gas-Machine, Anesthesia	BSZ	2	Exporter to the US	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Exporter to the US	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	KIJ	1	Exporter to the US	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	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 With Alarm	MLD	2	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
Stretcher, Wheeled	FPO	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, 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, 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
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Mammographic	IZH	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Exporter to the US	accessdata.fda.gov
Twister, Brace Setting	ITO	1	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
August 7, 2026	K261668	Venue Go	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary care Diagnostics, LLC	accessdata.fda.gov
February 11, 2025	K243620	Vivid iq	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
June 10, 2024	K240111	Venue	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
March 27, 2024	K233539	MAMMOMAT B.brilliant	MUE	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
November 7, 2023	K231989	LOGIQ E10s, LOGIQ Fortis	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Diagnostic,	accessdata.fda.gov
June 27, 2022	K220851	Venue	IYN	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
June 27, 2022	K220848	Venue Fit	IYN	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
May 11, 2022	K220446	Versana Balance	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
March 22, 2022	K214039	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
August 27, 2021	K211524	LOGIQ E10s, LOGIQ Fortis	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
January 8, 2021	K203114	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
November 18, 2020	K202233	Venue Go	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
July 23, 2020	K200743	Vivid E80/ Vivid E90/ Vivid E95	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound And	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
January 31, 2020	K193257	ACUSON Sequoia Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
September 18, 2019	K191663	Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0	IYN	Substantially Equivalent	Canon Medical Systems Corporation	accessdata.fda.gov
August 9, 2019	K191798	Versana Active	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
December 6, 2018	K181727	Vivid iq	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
November 15, 2018	K181985	Voluson E6, Voluson E8, Voluson E10	IYN	Substantially Equivalent	GE Healthcare	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
July 24, 2018	K180017	MX40 Release C.01	MHX	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
December 20, 2017	K173555	LOGIQ E10	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
November 17, 2017	K173023	Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
June 1, 2017	K170904	Biograph Horizon PET/CT	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
May 19, 2017	K170752	OEC Elite	OWB	Substantially Equivalent	Oec Medical Systems, Inc.	accessdata.fda.gov
April 7, 2017	K162838	Philips iCT CT System	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
November 9, 2016	K161768	LUCAS 3 Chest Compression System	DRM	Substantially Equivalent	Jolife AB	accessdata.fda.gov
September 1, 2016	K161567	SIGNA Voyager	LNH	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
August 8, 2016	K160743	Philips Ingenuity CT	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
April 1, 2016	K153486	Affirm Prone Biopsy System	IZH	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
March 29, 2016	K160621	SIGNAPioneer	LNH	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
March 25, 2016	K151765	SOMATOM Perspective	JAK	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
November 24, 2015	K150618	PENTAX Medical EPK-i7010 Video Processor with GI Family	PEA	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
November 24, 2015	K142955	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power	JAK	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
March 4, 2015	K150087	Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System	IYN	Substantially Equivalent	Ge Vingmed Ultrasound AS	accessdata.fda.gov
July 10, 2014	K133819	VERADIUS	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
May 15, 2014	K133664	ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS	KGI	Substantially Equivalent	Ge Medical Systems Ultrasound & Primary Care Diagn	accessdata.fda.gov
March 11, 2014	K132094	CIOS ALPHA	OWB	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.	accessdata.fda.gov
December 16, 2013	K132785	STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY	GCJ	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
August 30, 2013	K131576	OPTIMA CT660	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
August 29, 2013	K131780	EVIS EXERA III VIDEO SYSTEM	FDF	Substantially Equivalent	Olympus Medical Systems Corp.	accessdata.fda.gov
August 16, 2013	K131634	SYMBIA	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
June 18, 2013	K130499	IU22 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
May 21, 2013	K130842	ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES	IZI	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
February 22, 2013	K122286	MAMMOMAL INSPIRATION	MUE	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
February 8, 2013	K123596	OPTIMA CT520	JAK	Substantially Equivalent	Ge Hangwei Medical Systems Co., Ltd.	accessdata.fda.gov
January 29, 2013	K123873	CONTRAST ENHANCED DIGITAL MAMMOGRAPHY	MUE	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
October 12, 2012	K122445	AESPIRE 7900, AESPIRE VIEW	BSZ	Substantially Equivalent	Datex-Ohmeda	accessdata.fda.gov
June 12, 2012	K120833	DISCOVERY CT750 HD	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
May 23, 2012	K120579	SOMATOM DEFINITION EDGE	JAK	Substantially Equivalent	Siemens Medical Systems, Inc.	accessdata.fda.gov
December 22, 2011	K110798	SENOGRAPHE DS, SENOGRAPHE ESSENTIAL	MUE	Substantially Equivalent	General Electric Company	accessdata.fda.gov
December 20, 2011	K113598	POWER-LOAD COT FASTENER SYSTEM	FPO	Substantially Equivalent	Stryker Medical	accessdata.fda.gov
November 17, 2011	K113125	INTELLIVUE MX40 PATIENT MONITOR	DSI	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
January 20, 2011	K103762	SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE	DTQ	Substantially Equivalent	Sorin Group Deutschland GmbH	accessdata.fda.gov
June 17, 2009	K090422	LUCAS 2	DRM	Substantially Equivalent	Jolife AB	accessdata.fda.gov
March 11, 2009	K082937	LIFEPAK 15 MONITOR/DEFIBRILLATOR	MKJ	Substantially Equivalent	Physio-Control, Inc.	accessdata.fda.gov
March 1, 2005	K050297	SOMATOM EMOTION 16	JAK	Substantially Equivalent	Siemens Medical Solution, Inc. USA	accessdata.fda.gov
March 1, 2004	K040372	LIGHTSPEED 7.0 CT SCANNER SYSTEM	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 8, 2002	K023398	HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY	KGI	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
September 4, 1997	K972367	STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT	KIJ	Substantially Equivalent	Stryker Instruments	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 11, 2011	P080003	SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	OTE	10	November 24, 2025	accessdata.fda.gov
March 15, 2002	P010025	LORAD DIGITAL BREAST IMAGER	MUE	17	November 16, 2010	accessdata.fda.gov
January 28, 2000	P990066	GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM	MUE	36	November 5, 2010	accessdata.fda.gov

Compare with other makers

Updated August 7, 2026. 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.