The following data is part of a premarket notification filed by Koios Medical, Inc. with the FDA for Koios Ds For Breast.
| Device ID | K190442 |
| 510k Number | K190442 |
| Device Name: | Koios DS For Breast |
| Classification | Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Applicant | Koios Medical, Inc. 500 7th Avenue, 8th Floor New York, NY 10018 |
| Contact | Lev Barinov |
| Correspondent | Lev Barinov Koios Medical, Inc. 500 7th Avenue, 8th Floor New York, NY 10018 |
| Product Code | POK |
| CFR Regulation Number | 892.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-25 |
| Decision Date | 2019-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08600025457074 | K190442 | 000 |
| 00860002545707 | K190442 | 000 |