Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017604664

FEI Number

3017604664

Entity Name

AVICENNA.AI

City/State/Country

La Ciotat Bouches-du-Rhone, FR

Establishment Address

Espace Mistral B, 375 avenue du Mistral, La Ciotat Bouches-du-Rhone 13600, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Avicenna AI S.A.S. (Owner Number: 10077875)

Owner / Operator Contact Address

Espace Mistral B 375 Avenue du, Mistral La Ciotat, FR-13 13600, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233342

PMA Number

N/A

All Registered Proprietary Names

Viz PE CINA CHEST Viz AD Viz Pulmonary Embolism Clot Detection Viz Aortic Dissection Detection CINA-VCF CINA-iPE, VIZ iPE, Rapid iPE CINA StrokeViewer Hemorrhage Triaging CINA CINA CSPINE; VIZ CSPINE CINA-ASPECTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2021-06-01
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2024-06-17
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2024-03-26
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2020-10-05
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-05-25
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2024-09-26
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2024-03-26

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Avicenna AI S.A.S.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220709	Aidoc Medical , Ltd.	BriefCase	2022-10-07
K190362	Zebra Medical Vision, Ltd.	HealthPNX	2019-05-06
K251769	Precision Medical Ventures, Inc. Dba Revealdx	RevealAI-Lung	2026-01-30

Similar Registrations

Registration Number	Establishment Name	Location
3021915828	NICo-Lab B.V.	Amsterdam Noord-Holland, NL
3016727312	HEURON CO., LTD.	Seoul, KR
3023702863	Harrison-AI Medical Pty Ltd	Sydney New South Wales, AU
3004977335	Siemens Healthineers AG	FORCHHEIM Bavaria, DE
3017840913	QURE.AI TECHNOLOGIES PRIVATE LIMITED	Mumbai Maharashtra, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017604664. Last updated year: 2026. Please use registration number 3017604664 when referencing this establishment in official correspondence.