Cina Chest 1.0
by Avicenna.ai
Cina Chest 1.0 is a medical device (FDA Class II; FDA product code QAS, Radiological Computer-Assisted Triage And Notification Software) made by Avicenna.ai, cleared under FDA 510(k) K210237 on 19 May 2021 and listed in FDA GUDID since 2 Jun 2021 (UDI-DI B826CINACHEST100), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB826CINACHEST100 | Date2 Jun 2021 | StatusListed |
| United States | FDA 510(k) | NumberK210237 | Date19 May 2021 | StatusActive |
Official records
- FDA 510(k) database K210237
Across registries
- FDA 510(k) K210237 decided 19 May 2021 Active
- FDA GUDID UDI-DI B826CINACHEST100 listed 2 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K210237
- Listed FDA GUDID B826CINACHEST100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cina Chest
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.0
- Primary DI / UDI-DI
- B826CINACHEST100
- 510(k) Number
- FDA product code
- QAS
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2080
- GUDID distribution status
- In Commercial Distribution
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