The following data is part of a premarket notification filed by Adani with the FDA for Adani Mammoscan.
| Device ID | K172027 |
| 510k Number | K172027 |
| Device Name: | Adani MammoScan |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | ADANI Selitski St., 7 Minsk, BY 220075 |
| Contact | Vladimir Klokov |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, FL 34114 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2017-10-20 |
| Summary: | summary |