K213353 is an FDA 510(k) clearance for the Aorta-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 September 20, 2022, 347 days after receiving the submission on October 8, 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 | K213353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2021 |
| Decision Date | September 20, 2022 |
| Days to Decision | 347 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 |