The following data is part of a premarket notification filed by First Sense Medical, Llc with the FDA for Sentinel Breastscan Ii System.
| Device ID | K162767 |
| 510k Number | K162767 |
| Device Name: | Sentinel BreastScan II System |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | First Sense Medical, LLC 2001 Centerpoint Parkways, Suite 110 Pontiac, MI 48341 |
| Contact | Alan Alan Klevens |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-01-09 |
| Summary: | summary |