GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Registration Details

Registration Name: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Registration Number: 9613299
FEI Number: 3004571294
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 4 HAYOZMA ST.
City: TIRAT HACARMEL Haifa
Country: IL

Regulatory Submissions

510(k) Number: K180318

Owner / Operator

Firm Name: GE HealthCare Technologies Inc.
Operator Number: 9912004
Address: 3000 N. Grandview Blvd
City: Waukesha
State: WI
Postal Code: 53188
Country: US

US Agent

Business Name: GE HealthCare Technologies, Inc
Contact Name: Tracey Holevas
Address: 3000 N. Grandview BLVD
City: Waukesha
State: WI
ZIP: 53188
Country: US
Email: [email protected]
Phone: 262 3092157

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Table, Radiographic, Non-Tilting, Powered	IZZ	Class 2	Radiology	No	2004-09-24
System, Tomography, Computed, Emission	KPS	Class 2	Radiology	No	2018-05-30
System, Image Processing, Radiological	LLZ	Class 2	Radiology	No	2023-04-24
System, X-Ray, Tomography, Computed	JAK	Class 2	Radiology	No	2025-06-16
Cradle, Patient, Radiologic	KXH	Class 1	Radiology	No	2018-03-28
Camera, Scintillation (Gamma)	IYX	Class 1	Radiology	No	2017-01-25
Bed, Scanning, Nuclear	IYZ	Class 1	Radiology	No	1994-04-06
Holder, Head, Radiographic	IWY	Class 1	Radiology	No	2018-03-21

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 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 2 PROCESSING AND REVIEW WORKSTATION Clarify DL Infinia Table for Infinia Systems Infinia VC Hawkeye 4 Infinia Hawkeye 4 GE QUASAR NUCLEAR MEDICINE SYSTEM Infinia Table Discovery NM/CT 670 CZT NM/CT 870 CZT NM Patient Table Discovery MI Gen 2 Discovery Max Pro Discovery Future Discovery Power Max Apollo + Max Elite + Precision DL D670 HEAD HOLDER Low Dose CT Lung Cancer Screening Option for Qualified GE CT Systems UFC-VCT Discovery NM/CT 570c GE DISCOVERY NM/CT 570C

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility