Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010703925

FEI Number

3010703925

Entity Name

MAKAR CONSULTING PTY LTD

City/State/Country

Belrose New South Wales, AU

Establishment Address

1 Garigal Road, Belrose New South Wales 2085, AU

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Makar Consulting Pty Ltd (Owner Number: 10062928)

Owner / Operator Contact Address

1 Garigal Road, Belrose, AU-NSW 2085, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040372

PMA Number

N/A

All Registered Proprietary Names

GE MRI Coil GE Logiq P8 Hologic Selenia Dimensions Mammo GE Senographe Essential Siemens Cios C-Arm Hologic Horizon GE Logiq Fortis Lucas 3 Chest Compressor Power Load Cot Fastener Hologic Affirm Prone Sorin Heart Lung Hologic Mammo 113T tube GE Healthcare GE Venue Fit Philips Veradius C-Arm GE CT Scanner Olympus Stryker 1488 Siemens Perspective CT KPS - System, tomography, computed, emission Versana Active Siemens Biograph Siemens Emotion 16 Lifepak Philips Medical Siemens Symbia 16T Logiq P10 GE Healthcare Datex-Ohmeda Toshiba Medical OEC Elite Philips Brilliance 64 Siemens Inspiration Mammo Selenia Dimensions Mammography System Siemens Vivid E95 GE Venue Go Siemens Perspective CT Philips Ingenuity CT GE Optima 660 GE Lunar Prodigy Philips Healthcare Vivid E95 GE Healthcare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2024-10-21
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-10-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-22
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-01-07
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2026-04-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-09-12
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-09-12
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2025-09-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-11-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-11-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-11-19
DRM	Compressor, Cardiac, External	Cardiovascular	Class 2	870.5200	2025-12-18
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2026-03-27
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2025-04-07
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2026-05-24
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2025-03-05
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2021-09-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2021-09-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-10-30
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-10-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-10-30
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-09-12
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-09-12
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-09-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-06-28
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2021-03-14
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-03-14
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-03-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-04-05
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-06-28
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-07-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-07-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-12-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-12-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-12-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-04-23
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-04-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-01-07
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-09-08
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-09-08
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Cardiovascular	Class 2	870.5550	2023-09-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-09-08
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2023-09-08
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-09-08
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2023-09-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-09-08
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-01-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-01-26
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-01-26
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2022-01-26
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-01-26
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-01-26
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-01-26
DRW	Adaptor, Lead Switching, Electrocardiograph	Cardiovascular	Class 2	870.2350	2022-01-26
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2022-01-26
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-05-13
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-05-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-12-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-12-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-12-14
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2020-03-13
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2022-08-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-09-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-26
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-03-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-03-24
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-03-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-12-06
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-06-04
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-01-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-04-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-04-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-12-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-12-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-12-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-11-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-11-13
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-01-22
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-12-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-05-13
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2025-09-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-08-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-08-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-08-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-05-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-05-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-05-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-08-29

Official Correspondent

Richard Blunden

US Agent Details

Peter Pekalski Business: Vomark Technologies, Inc Email: admin@vomark.com Phone: (312) 2539892

Related Public Records

Same Entity

Makar Consulting Pty Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121249	Paramed S.R.L.	MULTIARRAY KIT	2012-06-12
K000935	Mri Devices Corp.	KFA-63 KNEE AND FOOT ARRAY	2000-04-07
K102889	Hitachi Medical Systems America, Inc.	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20
K110373	Esaote, S.p.A.	TEMPOROMANIBULAR COIL 15	2011-04-06
K030317	Midwest Rf, LLC	MODEL 1300GE-64: PEDIATRIC POSITIONER	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2020	Quality Electrodynamics LLC	2	TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020	Quality Electrodynamics LLC	2	TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020	Quality Electrodynamics LLC	2	TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010703925. Last updated year: 2026. Please use registration number 3010703925 when referencing this establishment in official correspondence.