The following data is part of a premarket notification filed by Therapixel with the FDA for Mammoscreen 2.0.
| Device ID | K211541 |
| 510k Number | K211541 |
| Device Name: | MammoScreen 2.0 |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Applicant | Therapixel 455 Promenade Des Anglais Nice, FR 06200 |
| Contact | Quentin De Snoeck |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroichet Drive Hillsborough, CA 94010 |
| Product Code | QDQ |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-19 |
| Decision Date | 2021-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B885MAML2US0 | K211541 | 000 |