Chest-CAD 1.0.0
Chest-CAD 1.0.0 is a X-ray image interpretive software (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 and listed in FDA GUDID since 26 Jul 2021 (UDI-DI 00852491008023), 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 | Number00852491008023 | Date26 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210666 | Date20 Jul 2021 | StatusActive |
Official records
- AccessGUDID record 00852491008023
- FDA 510(k) database K210666
Across registries
- FDA 510(k) K210666 decided 20 Jul 2021 Active
- FDA GUDID UDI-DI 00852491008023 listed 26 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K210666
- Listed FDA GUDID 00852491008023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Chest-CAD
- Generic name
- X-ray image interpretive software
- Model / reference
- 1.0.0
- Primary DI / UDI-DI
- 00852491008023
- 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
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MYN (Analyzer, Medical Image).
- Smile Dx® by Cube Click, Inc.
- Lung AI (LAI001) by Exo, Inc.
- Overjet Calculus Assist v1 by OVERJET
- QVCAD System (Version 3.3) by Qview Medical, Inc.
- Overjet Caries Assist-Pediatric v1 by OVERJET
- Rayvolve LN by AZMED
- Better Diagnostics Caries Assist (BDCA) Version 1.0 by BETTER DIAGNOSTICS AI CORP
- DeepTek CXR Analyzer v1.0 by Deeptek Medical Imaging Pvt, Ltd.
- Videa Dental Assist by Videahealth, Inc.
- Videa Dental AI by Videahealth, Inc.