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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Israel · Tirat Hacarmel

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 4Class II 4Class III 0

plus 94 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class II 4

32 including historic records

TWTaiwanTFDA

8valid device licences

Class II 8

SGSingaporeHSA SMDR

24device registrations

CLASS B 13CLASS C 11

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

IIa 3IIb 3

HKHong KongMDACS

10valid listings

Class II 5Class III 5

ILIsraelAMAR

25registrations

RURussiaRoszdravnadzor

8active registrations

Class 2a 1Class 2b 7

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States94 registration records, 4 510(k), 0 PMA, 4 excluded

Brazil4 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE Medical Systems Israel, Functional Imaging

FDA 510(k) clearances by year

12010 · K102231

12024 · K241665

22025 · K243605

FDA listed device types

System, Tomography, Computed, Emission 1System, Image Processing, Radiological 1System, X-Ray, Tomography, Computed 1Table, Radiographic, Non-Tilting, Powered 1Holder, Head, Radiographic 1Cradle, Patient, Radiologic 1Camera, Scintillation (Gamma) 1Bed, Scanning, Nuclear 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243605	Aurora	2025-01-17
US	K241350	Clarify DL	2025-01-03
US	K241665	Omni Legend	2024-08-08
BR	80071260136	Equipamento de Medicina Nuclear - linha NM 600	Class II
BR	80071260328	Estação de Trabalho de Processo e Revisão Xeleris	Class II
BR	80071260124	Sistema de Medicina Nuclear GE Discovery	Class II
CA	8875	VISION	Class II
CA	8877	VISION POWERSTATION	Class II
CA	14455	OPTIMA NX INTERGRATED MULTIDETECTOR IMAGING SYSTEM	Class II