Therapixel: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Therapixel” (first 2020, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 182 days. Since 2017 the median was 182 days, against 142 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 173 |
| 2021 | 1 | 191 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 153 |
| 2025 | 2 | 241 |
| 2026 | 1 | 113 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Therapixel took a median 182 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 5 | 5 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
Review panels
- Radiology (7)
Most recent Therapixel 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260714 | MammoScreen® (5) | QDQ | 2026-06-26 | 113 |
| K243685 | MammoScreen BD | QIH | 2025-08-22 | 266 |
| K243679 | MammoScreen® (4) | QDQ | 2025-07-03 | 216 |
| K241561 | MammoScreen BD | QIH | 2024-10-02 | 124 |
| K240301 | MammoScreen® (3) | QDQ | 2024-08-01 | 182 |
| K211541 | MammoScreen 2.0 | QDQ | 2021-11-26 | 191 |
| K192854 | MammoScreen | QDQ | 2020-03-25 | 173 |
Recalls
openFDA lists no recalls under a recalling firm named Therapixel.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Therapixel is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05800132: Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI (Recruiting, started 2023-06-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Therapixel?
FDA lists 7 510(k) clearances under the applicant name “Therapixel” (first 2020, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Therapixel?
The median time from FDA receipt to decision across 510(k)s cleared under the name Therapixel is 182 days. Since 2017: 182 days, versus 142 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Therapixel?
The most frequent FDA product codes under this applicant name are QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, 5); QIH (Automated Radiological Image Processing Software, 2).
Next steps
- See all 7 Therapixel clearances with predicates and recalls
- Run predicate analysis for product code QDQ, Therapixel's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.