Cina-Vcf 1.0
by Avicenna.ai
Cina-Vcf 1.0 is a medical device (FDA Class II; FDA product code QFM, Radiological Computer-Assisted Prioritization Software For Lesions) made by Avicenna.ai, cleared under FDA 510(k) K240612 on 31 May 2024 and listed in FDA GUDID since 20 Jun 2024 (UDI-DI B826CINAVCF100), 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 | NumberB826CINAVCF100 | Date20 Jun 2024 | StatusListed |
| United States | FDA 510(k) | NumberK240612 | Date31 May 2024 | StatusActive |
Official records
- FDA 510(k) database K240612
Across registries
- FDA 510(k) K240612 decided 31 May 2024 Active
- FDA GUDID UDI-DI B826CINAVCF100 listed 20 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K240612
- Listed FDA GUDID B826CINAVCF100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cina-Vcf
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.0
- Primary DI / UDI-DI
- B826CINAVCF100
- 510(k) Number
- FDA product code
- QFM
- 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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