CINA-iPE
by Avicenna.AI
Ref CINA-iPE
CINA-iPE is a medical device (EU MDR Class IIb) made by Avicenna.ai, registered in EUDAMED on 21 Aug 2024 (Basic UDI-DI ++B826CINAIPE103M) and cleared under FDA 510(k) K233968 on 13 Mar 2024, active as of 25 Oct 2026.
Active
CE MDR 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++B826CINAIPE103M +B826CINAIPE100 | Date21 Aug 2024 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK233968 | Date13 Mar 2024 | StatusActive |
Official records
- EUDAMED public site ++B826CINAIPE103M
- FDA 510(k) database K233968
Across registries
- EUDAMED Basic UDI-DI ++B826CINAIPE103M registered 21 Aug 2024 Active
- FDA 510(k) K233968 decided 13 Mar 2024 Active
Timeline
- Cleared FDA 510(k) K233968
- Registered EUDAMED ++B826CINAIPE103M
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Model / reference
- CINA-iPE
- Primary DI / UDI-DI
- +B826CINAIPE100
- Basic UDI-DI
- ++B826CINAIPE103M
- EMDN code
- Z11039092 Various radiodiagnostic and interventional instruments - medical device software
- Device class
- Class IIb
- Special device type
- Software
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000324
Similar devices in this category
Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE.