Cina-Aspects 1.5
by Avicenna.ai
Cina-Aspects 1.5 is a medical device (FDA Class II; FDA product code POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer) made by Avicenna.ai, cleared under FDA 510(k) K233342 on 15 Mar 2024 and listed in FDA GUDID since 29 Mar 2024 (UDI-DI B826CINAASPECTS150), 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 | NumberB826CINAASPECTS150 | Date29 Mar 2024 | StatusListed |
| United States | FDA 510(k) | NumberK233342 | Date15 Mar 2024 | StatusActive |
Official records
- FDA 510(k) database K233342
Across registries
- FDA 510(k) K233342 decided 15 Mar 2024 Active
- FDA GUDID UDI-DI B826CINAASPECTS150 listed 29 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K233342
- Listed FDA GUDID B826CINAASPECTS150
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cina-Aspects
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.5
- Primary DI / UDI-DI
- B826CINAASPECTS150
- 510(k) Number
- FDA product code
- POK
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2060
- GUDID distribution status
- In Commercial Distribution
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