HomeUSAToshiba Medical Systems

Toshiba Medical Systems

USA · Tustin
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
216510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 216 510(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
3active device licences
Class II 3
TWTaiwanTFDA
0valid device licences
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 States0 registration records, 216 510(k), 0 PMA, 3 excluded
Brazil0 confirmed, 1 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: TOSHIBA MEDICAL VISUALIZATION SYSTEMS EUROPE, LIMITED
Same-named companies — This database also contains companies with near-identical names: TOSHIBA MEDICAL VISUALIZATION SYSTEMS EUROPE, LIMITED. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Tustin

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

61996
41997
81998
81999
12000
52001
62002
42003
22004
72005
72006
82007
162008
62009
22010
102011
122012
32013
42014
32017

Registration details (sample)

MarketIdentifierNameClass / date
USK172878Vantage Titan 3T, MRT-3010/A7, M-Power GX2017-11-17
USK172188Aquilion Prime SP, TSX-303B/1, v8.42017-10-06
USK170909Infinix INFX-8000V, V6.402017-06-16
CA37811VOXAR 3DClass II
CA60758VOXAR COLONSCREEN SOFTWAREClass II
CA60759VOXAR CALSCREEN SOFTWAREClass II

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