Imbio CAC 2.0.0
by Imbio, LLC
Imbio CAC 2.0.0 is a Class II device made by Imbio, LLC, cleared under FDA 510(k) K230112 on 13 Jun 2023 and listed in FDA GUDID since 19 Jul 2023 (UDI-DI 00850894007797), active as of 22 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 | Number00850894007797 | Date19 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230112 | Date13 Jun 2023 | StatusActive |
Official records
- AccessGUDID record 00850894007797
- FDA 510(k) database K230112
Across registries
- FDA 510(k) K230112 decided 13 Jun 2023 Active
- FDA GUDID UDI-DI 00850894007797 listed 19 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K230112
- Listed FDA GUDID 00850894007797
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Imbio CAC
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 2.0.0
- Primary DI / UDI-DI
- 00850894007797
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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