MammoScreen
Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Therapixel
The following data is part of a premarket notification filed by Therapixel with the FDA for Mammoscreen.
Pre-market Notification Details
| Device ID | K192854 |
| 510k Number | K192854 |
| Device Name: | MammoScreen |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Applicant | Therapixel Village By CA - Le Theseus, Rue Claude Daunesse Valbonne, FR 06560 |
| Contact | Quentin De Snoeck |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroihet 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 | 2019-10-04 |
| Decision Date | 2020-03-25 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B885MAML0 | K192854 | 000 |
Trademark Results [MammoScreen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOSCREEN 88423365 not registered Live/Pending |
Therapixel SA 2019-05-09 |
 MAMMOSCREEN 73686955 1524771 Dead/Cancelled |
HEALTH CARE RESOURCES, INC. 1987-09-29 |
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