EvERX PTY LTD

FDA Device Registration & Listing · Sydney New South Wales, AU · Registration 3008496839

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008496839
FEI Number
3008496839
Entity Name
EvERX PTY LTD
City/State/Country
Sydney New South Wales, AU
Establishment Address
3 / 185 Briens Rd, Northmead, Sydney New South Wales 2152, AU
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
EverX / Bindra (Owner Number: 10033159)
Owner / Operator Contact Address
3 / 185 Briens Rd, Northmead, Sydney, AU-NSW 2152, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K101347
PMA Number
N/A

All Registered Proprietary Names

FUJI AMULETINNOVALITY DIGITAL BREAST TOMOSYNTHESIS SIEMENS ARCADIS VARIC Hologic SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM SIEMENS SOMATOM PERSPECTIVE 16 Siemens Magnetom Symphony MRI Siemens Acuson S2000 ABVS Siemens Definition AS 64-Slice Siemens Scope CT Scanner AVEA 17310 VENTILATOR GE OPTIMA MR450W OPTIMA NM/CT 640 Siemens Somatom Definition Flash GE INNOVA IGS 520 GE LUNAR PRODIGY SIEMENS E.CAM Siemens Somatom Definition Edge GE DISCOVERY CT750HD GE OEC MINI 6800 Philips Epiq 7G Shimadzu Mobile Dart Evolution GE LOGIQ E9 Hologic Selenia Dimensions System GE INNOVA 2100 CATHLAB TOSHIBA APLIO 500 MODEL TUS-A500 GE Seno DS Digital GE OEC 9900 ELITE C-ARM Siemens Mammomat Inspiration Prime CAREFUSION AVEA VENTILATOR Toshiba Aquilion 64-Slice CT, Model TSX-101A GE LIGHTSPEED VCT 64 SLICE Philips Azurion 7 Cathlab GE OEC 9800 C-ARM GE Optima CT580 SIEMENS ACUSON S2000 DISCOVERY MODEL NM/CT 670 SIEMENS INSPIRATION DIGITAL MAMMOGRAPHY HOLOGIC FLUOROSCAN INSIGHT FD MINI C-ARM GE SENO ESSENTIAL W/ TOMO SIEMENS SOMATOM EMOTION 16 GE Brivo XR385(DR X-Ray) GE OPTIMA 660 128-SLICE CT GE Discovery XR650 X-Ray Toshiba Aquilion One Vision CT ENCOR BREAST BIOPSY SYSTEM GE Discovery PET/CT 690 Siemens Artis Zee Angiographic System GE Infinia Hawkeye IV SIEMENS ARCADIS AVANTIC SIEMENS MAGNETOM SKYRA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OTE Digital Breast Tomosynthesis Unknown Class 3 N/A 2024-04-24
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2022-07-18
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2022-07-18
OTE Digital Breast Tomosynthesis Unknown Class 3 N/A 2022-12-22
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-12-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-01-09
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-04-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2019-04-17
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-12-22
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2023-03-12
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-11-17
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2022-04-26
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-04-26
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-08-15
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-02-23
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-02-23
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2026-02-23
KGI Densitometer, Bone Radiology Class 2 892.1170 2023-03-13
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-02-20
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-02-20
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-05-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2017-09-19
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2020-10-12
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-04-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-04-24
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-04-24
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2020-10-12
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-11-23
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-11-23
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-11-23
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2022-12-22
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2023-09-01
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2023-09-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-04-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-04-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-04-24
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2024-01-02
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2018-06-06
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2018-06-06
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2018-06-06
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2025-05-21
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2023-09-01
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-06-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-04-28
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-02-09
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-02-09
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2018-07-13
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2018-07-13
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2018-07-13
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-04-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-03-12
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-03-12
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-03-12
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2023-03-12
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-11-02
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2023-11-02
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2022-11-23
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2023-09-01
IZH System, X-Ray, Mammographic Radiology Class 2 892.1710 2022-08-15
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2019-11-06
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2025-05-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-06-17
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2024-11-17
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2024-11-17
IZF System, X-Ray, Tomographic Radiology Class 2 892.1740 2024-11-17
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-11-02
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-09-01
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-11-17
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2021-05-13
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2019-04-17
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2018-11-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-03-24

Official Correspondent

Ravinder Bindra

US Agent Details

Hamish Dunn Business: EverX USA LLC Email: hdunn@everxusa.com Phone: (760) 4297019

Related Public Records

Same Entity

EverX / Bindra
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
K863853 Superior Medical Products EAZY COVERS 1987-03-06
K953974 Medivision Medical Imaging, Ltd. CAMVISION 1000 1996-09-09
K024012 Ge Oec Medical Systems OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM 2003-03-20
K970608 Guidant Cardiac and Vascular Surgery EVT MARKER BOARD 1997-04-21
K203010 Apelem-Dms Group Platinum dRF Imaging System 2021-01-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-2219-2025 FUJIFILM Healthcare Americas Corporation 3
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Z-0001-2007 GE OEC Medical Systems, Inc 2
GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009 Philips Medical Systems North America Co. Phillips 2
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010 Ge Healthcare 2
GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010 Ge Healthcare 2
GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.

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3012127758 Siemens Healthcare Limited Oakville Ontario, CA
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008496839. Last updated year: 2026. Please use registration number 3008496839 when referencing this establishment in official correspondence.
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