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Ge Oec Medical Systems, Inc.

USA · Salt Lake City

✓ 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

4listed device types

Class I 1Class II 3Class III 0

plus 22 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

7active device licences

Class III 7

22 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 2IIa 1IIb 4

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States22 registration records, 22 510(k), 0 PMA, 2 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: GE OEC MEDICAL SYSTEMS, INC · GE OEC MEDICAL SYSTEMS INC.

FDA 510(k) clearances by year

12001

22002

12003

32004

22005

12006

12008

12011

22012

12013

12014

32017

12019

12021

12024

FDA listed device types

Image-Intensified Fluoroscopic X-Ray System, Mobile 1Interventional Fluoroscopic X-Ray System 1System, X-Ray, Fluoroscopic, Image-Intensified 1Monitor, Patient Position, Light-Beam 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233669	OEC 3D	2024-03-28
US	K203346	OEC 3D	2021-03-05
US	K192819	OEC Elite	2019-11-08
CA	15552	SERIES/COMPACT 7700 MOBILE DIGITAL IMAGING SYSTEM	Class III
CA	15714	SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM	Class III
CA	16095	MINI-6600 (SERIES 6600) DIGITAL IMOBILE C-ARM	Class III