Aorta-CAD 1.0.0
Aorta-CAD 1.0.0, a X-ray image interpretive software (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Imagen Technologies, Inc., was cleared under FDA 510(k) K213353 on 20 Sep 2022 and listed in FDA GUDID on 6 Apr 2023 (UDI-DI 00852491008030); the registry lists it as not in commercial distribution (GUDID) 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 | Number00852491008030 | Date6 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213353 | Date20 Sep 2022 | StatusActive |
Official records
- AccessGUDID record 00852491008030
- FDA 510(k) database K213353
Across registries
- FDA 510(k) K213353 decided 20 Sep 2022 Active
- FDA GUDID UDI-DI 00852491008030 listed 6 Apr 2023 Listed
Timeline
- Cleared FDA 510(k) K213353
- Listed FDA GUDID 00852491008030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aorta-CAD
- Generic name
- X-ray image interpretive software
- Model / reference
- 1.0.0
- Primary DI / UDI-DI
- 00852491008030
- 510(k) Number
- FDA product code
- MYN
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2070
- GUDID distribution status
- Not in Commercial Distribution
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