The following data is part of a premarket notification filed by Imagen Technologies, Inc with the FDA for Chest-cad.
| Device ID | K210666 |
| 510k Number | K210666 |
| Device Name: | Chest-CAD |
| Classification | Analyzer, Medical Image |
| Applicant | Imagen Technologies, Inc 151 West 26th Street, Suite 1001 New York, NY 10001 |
| Contact | Robert Lindsey |
| Correspondent | Robert Lindsey Imagen Technologies, Inc 151 West 26th Street, 10th Floor New York, NY 10001 |
| Product Code | MYN |
| CFR Regulation Number | 892.2070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-05 |
| Decision Date | 2021-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852491008023 | K210666 | 000 |