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Shimadzu Corporation Medical Systems

USA · Torrance

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

18listed device types

Class I 4Class II 14Class III 0

plus 37 registration records and 93 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

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 States37 registration records, 93 510(k), 0 PMA, 6 excluded

Brazil0 confirmed, 4 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Same-named companies — This database also contains companies with near-identical names: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

51989

71990

151991

271992

21993

21994

71995

61996

31997

21998

11999

12000

22001

32005

32006

42008

12021

12022

12024

FDA listed device types

showing 8 of 18

Holder, Radiographic Cassette, Wall-Mounted 1Generator, High-Voltage, X-Ray, Diagnostic 1Assembly, Tube Housing, X-Ray, Diagnostic 1Tube Mount, X-Ray, Diagnostic 1Image-Intensified Fluoroscopic X-Ray System, Mobile 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1

Market	Identifier	Name	Class / date
US	K240827	SET-5002	2024-05-24
US	K221922	Trinias	2022-07-28
US	K203535	Trinias	2021-04-28

Shimadzu Corporation Medical Systems

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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