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Home›USA›CANON MEDICAL INFORMATICS, INC.

CANON MEDICAL INFORMATICS, INC.

USA · Minnetonka
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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
12listed device types
Class I 2Class II 10Class III 0
plus 69 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
5active device licences
Class II 5
8 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 2IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States69 registration records, 6 510(k), 0 PMA, 8 excluded
Brazil1 confirmed, 0 excluded
Canada5 confirmed, 1 excluded
Manufacturer names merged into this page: CANON MEDICAL INFORMATICS, INC. · Medical Informatics Corp. · Canon Medical Informatics A/S · CANON MEDICAL INFORMATICS A/S · CANON MEDICAL INFORMATICS, INC
Same-named companies — This database also contains companies with near-identical names: Canon Medical Informatics A/S. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Minnetonka

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12015 · K143304
12022 · K222662
12023 · K223261
22025 · K252217
12026 · K260324

FDA listed device types

showing 8 of 12
System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, Tomography, Computed, Emission 1System, Nuclear Magnetic Resonance Imaging 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1System, Imaging, Pulsed Doppler, Ultrasonic 1System, X-Ray, Tomography, Computed 1Computer, Diagnostic, Programmable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260324Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning2026-05-22
USK252217CT VScore+2025-11-28
USK243240Vitrea CT VScore2025-04-10
BR10295030090SOFTWARE DE PROCESSAMENTO DE IMAGENSClass II
CA61192INNERVIEWGIClass II
CA70572VITALCONNECTClass II
CA77979VITREA FXClass II

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