Data / Medical devices / France / Avicenna.ai
Avicenna.ai: FDA-registered device maker in La Ciotat Bouches-du-Rhone, France, 7 510(k) clearances
Avicenna.ai is registered with the FDA (registration 3017604664) in La Ciotat Bouches-du-Rhone, France. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017604664
- Address
- Espace Mistral B 375 avenue du Mistral, La Ciotat Bouches-du-Rhone, France, 13600
- Owner or operator
- Avicenna AI S.A.S. (10077875)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 5, 2020
- Registered through
- 2026
- Brand names listed
- CINA, CINA CHEST, CINA CSPINE; VIZ CSPINE, CINA-ASPECTS, CINA-VCF, CINA-iPE, VIZ iPE, Rapid iPE, StrokeViewer Hemorrhage Triaging, VIZ ASPECTS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Triage And Notification Software | QAS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2024 | K240942 | CINA-CSpine | QAS | Substantially Equivalent | Avicenna.Ai | accessdata.fda.gov |
| May 31, 2024 | K240612 | CINA-VCF | QFM | Substantially Equivalent | Avicenna.Ai | accessdata.fda.gov |
| March 15, 2024 | K233342 | CINA-ASPECTS | POK | Substantially Equivalent | Avicenna.Ai | accessdata.fda.gov |
| March 13, 2024 | K233968 | CINA-iPE | QAS | Substantially Equivalent | Avicenna.Ai | accessdata.fda.gov |
| November 22, 2022 | K221716 | CINA | QAS | Substantially Equivalent | Avicenna.Ai | accessdata.fda.gov |
| May 19, 2021 | K210237 | CINA CHEST | QAS | Substantially Equivalent | Avicenna.Ai | accessdata.fda.gov |
| June 24, 2020 | K200855 | CINA | QAS | Substantially Equivalent | Avicenna.Ai | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Computer-Assisted Triage And Notification Software
- All makers of Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- All makers of Radiological Computer-Assisted Prioritization Software For Lesions
Updated September 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.