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Oec Medical Systems, Inc.

USA · Salt Lake City

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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

Oec Medical Systems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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