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CANON MEDICAL SYSTEMS, USA.

USA · Boca Raton

✓ 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

3listed device types

Class I 0Class II 3Class III 0

plus 13 registration records and 146 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

30active device licences

Class II 21Class III 9

72 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 States13 registration records, 146 510(k), 0 PMA, 15 excluded

Brazil0 confirmed, 6 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada30 confirmed, 5 excluded

Manufacturer names merged into this page: Canon Medical Diagnostics USA, Inc. · CANON MEDICAL SYSTEMS CORPORATION · CANON MEDICAL SYSTEMS, USA.

FDA 510(k) clearances by year

11990

11991

61994

31995

11997

21998

11999

12000

32002

32003

12009

162018

102019

152020

152021

102022

102023

82024

92025

52026

FDA listed device types

Ige, Antigen, Antiserum, Control 1System, Test, Radioallergosorbent (Rast) Immunological 1System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253596	Aquilion ONE (TSX-308A/TSX-306A) V2.0	2026-05-20
US	K253625	Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR	2026-03-27
US	K260078	Aquilion ServeSP (TSX-307B) V2.0	2026-03-13
CA	64883	INFINIX VB-I	Class III
CA	64888	INFINIX CS-I	Class III
CA	64890	INFINIX VS-I	Class III

CANON MEDICAL SYSTEMS, USA.

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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