Data / Medical devices / Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Radiological Computer Assisted Detection/Diagnosis Software For Fracture (QBS): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Radiological Computer Assisted Detection/Diagnosis Software For Fracture (product code QBS, Class 2, 21 CFR 892.2090). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on October 20, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- QBS
- Device class
- 2
- Regulation
- 892.2090
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| France | 3 |
| United States | 2 |
| Mexico | 1 |
| India | 1 |
| Belgium | 1 |
Makers of Radiological Computer Assisted Detection/Diagnosis Software For Fracture
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 |
|---|---|---|---|---|---|---|---|---|
| Azmed SAS | Paris, France | Complaint file establishment, Manufacturer | 2 | August 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Gleamer | Paris Ile-de-France, France | Manufacturer | 2 | March 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems Monterrey Mexico, S.A. De C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 1 | May 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems, LLC | Waukesha, WI, United States | Manufacturer | 1 | May 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Imagen Technologies, Inc. | New York, NY, United States | Complaint file establishment, Manufacturer | 1 | July 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Milvue | Paris Ile-de-France, France | Manufacturer | 1 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| WIPRO GE HEALTHCARE PRIVATE Ltd. | BANGALORE Karnataka, India | Specification developer | 1 | May 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| icometrix | Leuven Vlaams Brabant, Belgium | Manufacturer | 1 | November 7, 2024 | 0 | 0 | 0 | api.fda.gov |
Updated October 20, 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.