ClariSIGMAM 1.1.7
by ClariPI Inc.
ClariSIGMAM 1.1.7 is a Class II device made by ClariPI Inc., cleared under FDA 510(k) K203785 on 10 Sep 2021 and listed in FDA GUDID since 31 Aug 2023 (UDI-DI 08800046800013), 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 | Number08800046800013 | Date31 Aug 2023 | StatusListed |
| United States | FDA 510(k) | NumberK203785 | Date10 Sep 2021 | StatusActive |
Official records
- AccessGUDID record 08800046800013
- FDA 510(k) database K203785
Across registries
- FDA 510(k) K203785 decided 10 Sep 2021 Active
- FDA GUDID UDI-DI 08800046800013 listed 31 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K203785
- Listed FDA GUDID 08800046800013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ClariSIGMAM
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.1.7
- Primary DI / UDI-DI
- 08800046800013
- 510(k) Number
- FDA product code
- QIH
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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