GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Device Registration & Listing · TIRAT HACARMEL Haifa, IL · Registration 9613299

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
9613299
FEI Number
3004571294
Entity Name
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
City/State/Country
TIRAT HACARMEL Haifa, IL
Establishment Address
4 HAYOZMA ST., TIRAT HACARMEL Haifa 30200, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GE HealthCare Technologies Inc. (Owner Number: 9912004)
Owner / Operator Contact Address
3000 N. Grandview Blvd, Waukesha, WI 53188, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NG2000 ELITE HEAVY TABLE GT1700V(GT1700V N9 ED3, GT1700V) VT1700V(GT1700V N9 ED3) GT1700V (GT1700V N9 ED3, GT1700V) VT1700 (GT1700 N9 ED3) VT2000X(GT2000x) Lite (LITE TABLE N9 ED3, Lite Table) NG 2000 Table NM/CT Patient Table VT2000 (GT2000 N9 ED3) Kunlun Table NG2000V table G3 RAD Elevation Table Standard table NG1700 Patient Table Table (Model: GCTBL-C4) Table (Model: GCTBL-C33) NG LITE 1700 (NG1700 ELITE STANDARD TABLE) NG2000SV Table NG LITE 2000 (NG2000 ELITE HEAVY TABLE) NG2000SV TABLE NG1700 ELITE STANDARD TABLE Radiographic Table (Model: VFTBL-1) NG1700SV Table Table (Model: GCTBL-C3333) NG1700SV TABLE PET Digital Gating MotionFree Xeleris V Processing and Review System Aurora INFINIA INFINIA VC IFINIA Hawkeye 4 INFINIA VC Hawkeye 4 HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA NM600 INFANT SCAN SUPPORT XELERIS XELERIS 3 PROCESSING AND REVIEW WORKSTATION Xeleris 3 Millennium MPR Millennium MPR TF Millennium MPS PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS Millennium MG MILLENNIUM MT NUCLEAR MEDICINE MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS StarGuide StarGuide Plus Ventri 1.1 Discovery NM 530c Discovery NM/CT 670 Pro Discovery NM/CT 670 ES NM/CT 870 DR Discovery NM/CT 670 Discovery 670 DR Discovery MI Columbia Discovery MI Discovery Max Discovery MI Gen2 Discovery Max+ Discovery IQ Discovery IQ Clarity Volume Viewer Volume Viewer Apps Dynamic VUE NM 830 Discovery NM 630 MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE Xeleris 3.1 Volumetrix MI XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION DaTQUANT Ventri Brivo NM 615 MyoSPECT MyoSPECT ES Optima NM/CT 640 Aurora NM/CT 860 NM/CT 850 NM/CT 850 CT system NM/CT 860 CT system Discovery NM 750b Biopsy Discovery PET/CT 710-64 Discovery PET/CT 710 Clarity Edition Discovery PET/CT 610 Discovery MI Digital Ready Discovery PET/CT 710 Clarity Xeleris 4 Processing and Review Workstation Xeleris 4 DR Processing and Review Workstation Discovery NM 750b Max Elite Omni Legend Max Apollo XELERIS 2 XELERIS XELERIS 2 PROCESSING AND REVIEW WORKSTATION Clarify DL Infinia Table for Infinia Systems INFINIA Infinia VC Hawkeye 4 Infinia Hawkeye 4 INFINIA VC GE QUASAR NUCLEAR MEDICINE SYSTEM Infinia Table Discovery NM/CT 670 CZT NM/CT 870 CZT NM Patient Table NM/CT Patient Table

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZZ Table, Radiographic, Non-Tilting, Powered Radiology Class 2 892.1980 2004-09-24
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2018-05-30
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-04-24
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-06-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-06-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2007-11-04
KXH Cradle, Patient, Radiologic Radiology Class 1 892.1830 2018-03-28
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2010-06-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2021-05-04
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2021-05-04
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2010-06-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-08-12
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2016-08-12
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2014-09-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2010-06-23
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2011-07-07
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2012-04-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-10-29
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2012-01-11
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2012-01-11
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2021-08-31
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2012-05-02
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2012-05-02
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-02-19
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-02-19
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2018-04-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-04-18
IYX Camera, Scintillation (Gamma) Radiology Class 1 892.1100 2017-01-25
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2014-04-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-03-31
IYX Camera, Scintillation (Gamma) Radiology Class 1 892.1100 2010-11-09
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2022-09-06
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-09-06
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2007-11-04
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-01-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-01-07
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2016-02-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-02-29
IYZ Bed, Scanning, Nuclear Radiology Class 1 892.1350 1994-04-06

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

GE HealthCare Technologies Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007120336 GE Healthcare Magyarorszag Kft. Budapest, HU
3015060224 IMACTIS, SAS SAINT MARTIN D'HERES, FR
2122726 GE MEDICAL SYSTEMS, LLC Milwaukee, WI, US
9617766 GE BE PRIVATE LIMITED WHITEFIELD, BANGALORE Karnataka, IN
9710090 GE ULTRASOUND KOREA, LTD. Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033956 Is2 Research, Inc. MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) 2004-01-20
K923309 GE Medical Systems ARGUS PET SYSTEM 1992-09-29
K101768 Miegmbh MIE SCINTRON GAMMA CAMERA SYSTEMS 2010-10-05
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2016 Toshiba American Medical Systems Inc 2
Celesteion PCA-9000A/2 PET/CT System
Z-0012-05 General Electric Med Systems LLC 2
Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Z-0013-2007 Philips Medical Systems (Cleveland) Inc 2
Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
Z-0014-2007 Philips Medical Systems (Cleveland) Inc 2
Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.
Z-0024-2014 GE Healthcare, LLC 2
GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

Similar Registrations

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3008284470 GE Healthcare (China) Co., Ltd. Beijing, CN
3005778458 CARESTREAM HEALTH, INC., GLOBAL R&D CENTER SHANGHAI, CN
2243057 Accogent Pausch Tinton Falls, NJ, US
3012569470 VISARIS D.O.O. Zemun Beograd, RS
9612283 GE Healthcare Japan Corporation HINO-SHI Tokyo, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613299. Last updated year: 2026. Please use registration number 9613299 when referencing this establishment in official correspondence.
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