Data / Medical devices / United States / Therapixel Inc.
Therapixel Inc.: FDA-registered device maker in Chicago, IL, United States, 5 510(k) clearances
Therapixel Inc. is registered with the FDA (registration 3016759115) in Chicago, IL, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016759115
- Address
- 1700 W Irving Park Rd ST. 209A, Chicago, IL, United States, 60613
- Owner or operator
- THERAPIXEL (10071453)
- Roles
- Complaint file establishment
- First device listed
- December 16, 2021
- Registered through
- 2026
- Brand names listed
- Genius AI Detection PRO Density, Genius AI Detection PRO Image Quality for Quality, Genius AI® Detection PRO, MammoScreen, MammoScreen 3, MammoScreen 4, MammoScreen BD, MammoScreen QC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Complaint file establishment | accessdata.fda.gov |
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 22, 2025 | K243685 | MammoScreen BD | QIH | Substantially Equivalent | Therapixel | accessdata.fda.gov |
| July 3, 2025 | K243679 | MammoScreen® (4) | QDQ | Substantially Equivalent | Therapixel | accessdata.fda.gov |
| October 2, 2024 | K241561 | MammoScreen BD | QIH | Substantially Equivalent | Therapixel | accessdata.fda.gov |
| August 1, 2024 | K240301 | MammoScreen® (3) | QDQ | Substantially Equivalent | Therapixel | accessdata.fda.gov |
| November 26, 2021 | K211541 | MammoScreen 2.0 | QDQ | Substantially Equivalent | Therapixel | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of Automated Radiological Image Processing Software
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Updated August 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.