Aorta-CAD
510(k) K213353
Aorta-CAD is a medical device (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Imagen Technologies, Inc., cleared under FDA 510(k) K213353 on 20 Sep 2022, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213353 | Date20 Sep 2022 | StatusActive |
Official records
- FDA 510(k) database K213353
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MYN
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2070
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K213353
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Aorta-CAD 1.0.0 | 1.0.0 | 00852491008030 | — | No longer on the market |
| ChestSuite 1.0.0 | 1.0.0 | 00852491008047 | — | On the market |
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