Chest-CAD
510(k) K210666
Chest-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) K210666 on 20 Jul 2021, active as of 10 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 | NumberK210666 | Date20 Jul 2021 | StatusActive |
Official records
- FDA 510(k) database K210666
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- Withdrawn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 K210666
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 | |||
|---|---|---|---|---|
| Chest-CAD 1.0.0 | 1.0.0 | 00852491008023 | — | On the market |
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