Data / Medical devices / Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer (QDQ): 9 FDA-registered makers in 6 countries
9 establishments in 6 countries are registered with the FDA to make Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer (product code QDQ, Class 2, 21 CFR 892.2090). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on September 14, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QDQ
- Device class
- 2
- Regulation
- 892.2090
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Netherlands | 1 |
| South Korea | 1 |
| France | 1 |
| Australia | 1 |
| Spain | 1 |
Makers of Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Screenpoint Medical | Nijmegen Gelderland, Netherlands | Complaint file establishment, Manufacturer | 7 | August 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Deephealth | Somerville, MA, United States | Manufacturer | 6 | June 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Lunit Inc. | Seoul, South Korea | Complaint file establishment, Manufacturer | 5 | April 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer | 4 | July 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Icad Inc. | Nashua, NH, United States | Manufacturer | 4 | November 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Therapixel | Nice Alpes-Maritimes, France | Complaint file establishment, Manufacturer | 3 | July 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| See-Mode Technologies Pty Ltd | Melbourne Victoria, Australia | Manufacturer | 2 | July 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bot Image, Inc. | Omaha, NE, United States | Manufacturer | 1 | July 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Quibim S.L. | Valencia Valencia(Province), Spain | Manufacturer | 1 | March 18, 2025 | 0 | 0 | 0 | api.fda.gov |
Updated September 14, 2026. 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.