Cina-Chest
by Avicenna.AI
Ref CINA-CHEST
Cina-Chest is a medical device (EU MDR Class IIb) made by Avicenna.ai, registered in EUDAMED on 4 Jul 2024 (Basic UDI-DI ++B826CINACHEST10VN) and cleared under FDA 510(k) K210237 on 19 May 2021, active as of 23 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++B826CINACHEST10VN +B826CINACHEST100 | Date4 Jul 2024 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK210237 | Date19 May 2021 | StatusActive |
Official records
- EUDAMED public site ++B826CINACHEST10VN
- FDA 510(k) database K210237
Across registries
- EUDAMED Basic UDI-DI ++B826CINACHEST10VN registered 4 Jul 2024 Active
- FDA 510(k) K210237 decided 19 May 2021 Active
Timeline
- Cleared FDA 510(k) K210237
- Registered EUDAMED ++B826CINACHEST10VN
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Model / reference
- CINA-CHEST
- Primary DI / UDI-DI
- +B826CINACHEST100
- Basic UDI-DI
- ++B826CINACHEST10VN
- 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
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