K210666 is an FDA 510(k) clearance for the Chest-CAD. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Imagen Technologies, Inc. (New York, US). The FDA issued a Cleared decision on July 20, 2021, 137 days after receiving the submission on March 5, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2070. For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers.
| 510(k) Number | K210666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2021 |
| Decision Date | July 20, 2021 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MYN - Analyzer, Medical Image |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2070 |
| Definition | For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers |