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AVICENNA.AI

France · La Ciotat

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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 7 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIb 3

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 States7 registration records, 7 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: AVICENNA.AI

FDA 510(k) clearances by year

12020 · K200855

12021 · K210237

12022 · K221716

42024 · K240942

FDA listed device types

Radiological Computer-Assisted Prioritization Software For Lesions 1Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer 1Radiological Computer-Assisted Triage And Notification Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240942	CINA-CSpine	2024-09-12
US	K240612	CINA-VCF	2024-05-31
US	K233342	CINA-ASPECTS	2024-03-15
BR	80102512688	Software de análise de imagens médicas	Class II
BR	80102512689	Software de análise de imagens médicas	Class II
BR	80102512690	Software de análise de imagens médicas	Class II

AVICENNA.AI

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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