GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Device Registration & Listing · Haifa, IL · Registration 3027338963

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
3027338963
FEI Number
3027338963
Entity Name
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
City/State/Country
Haifa, IL
Establishment Address
Andrei Sakharov St 9, Haifa 3508415, IL
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
PMA Number
N/A

All Registered Proprietary Names

XELERIS 2 XELERIS XELERIS 2 PROCESSING AND REVIEW WORKSTATION PET Digital Gating MotionFree Xeleris V Processing and Review System NM600 INFANT SCAN SUPPORT Discovery PET/CT 710-64 Discovery PET/CT 710 Clarity Edition Discovery PET/CT 610 Discovery MI Digital Ready Discovery PET/CT 710 Clarity Brivo NM 615 Discovery MI Columbia Discovery MI Discovery Max Discovery MI Gen2 Discovery Max+ Discovery NM/CT 670 Pro Discovery NM/CT 670 ES NM/CT 870 DR Discovery NM/CT 670 Discovery 670 DR Millennium MPR Millennium MPR TF Millennium MPS PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS Discovery NM 750b Biopsy NM 830 Discovery NM 630 D670 HEAD HOLDER 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 UFC-VCT Discovery NM/CT 570c GE DISCOVERY NM/CT 570C Volume Viewer Volume Viewer Apps Dynamic VUE Discovery VCT-RX Discovery VCT Discovery RX VCT Precision DL Discovery NM 750b NM Patient Table NM/CT Patient Table Discovery IQ Discovery IQ Clarity Disocvery PET/CT 610 Clarity Discovery PET/CT 690 Discovery PET/CT 600 Optima 560 / Discovery 690 Elite Discovery PET/CT 610 Discovery PET/CT 710 Optima PET/CT 560 Optima PET/CT 560FX Xeleris 4 Processing and Review Workstation Xeleris 4 DR Processing and Review Workstation 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 Millennium MG MILLENNIUM MT NUCLEAR MEDICINE MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS Discovery MI Gen 2 Discovery MI Gen2 Discovery Max Pro Discovery Future Discovery Power Ventri 1.1 Discovery NM 530c MyoSPECT MyoSPECT ES Ventri

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2007-11-04
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
KXH Cradle, Patient, Radiologic Radiology Class 1 892.1830 2018-03-28
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2014-04-18
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
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
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
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
IYX Camera, Scintillation (Gamma) Radiology Class 1 892.1100 2017-01-25
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2011-07-07
IWY Holder, Head, Radiographic Radiology Class 1 892.1920 2018-03-21
IZZ Table, Radiographic, Non-Tilting, Powered Radiology Class 2 892.1980 2004-09-24
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2010-06-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2010-06-09
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-09
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2023-05-15
IYX Camera, Scintillation (Gamma) Radiology Class 1 892.1100 2010-11-09
IYZ Bed, Scanning, Nuclear Radiology Class 1 892.1350 1994-04-06
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2014-09-18
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-09
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-03-31
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
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2021-08-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2021-08-23
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2021-08-31
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2010-06-16

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
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31
K122260 Aycan Digitalsysteme GmbH AYCAN MOBILE 2012-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027338963. Last updated year: 2026. Please use registration number 3027338963 when referencing this establishment in official correspondence.
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