Data / Medical devices / Radiological Computer-Assisted Prioritization Software For Lesions / United States
FDA-registered makers of Radiological Computer-Assisted Prioritization Software For Lesions in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Radiological Computer-Assisted Prioritization Software For Lesions (product code QFM). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Radiological Computer-Assisted Prioritization Software For Lesions
- Product code
- QFM
- Country
- United States
Makers of Radiological Computer-Assisted Prioritization Software For Lesions in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medcognetics, Inc | Dallas, TX, United States | Manufacturer | 2 | December 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Viz.ai, Inc. | Cary, NC, United States | Complaint file establishment, Specification developer | 2 | March 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Curemetrix, Inc. | San Diego, CA, United States | Manufacturer | 1 | March 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Deephealth | Somerville, MA, United States | Manufacturer | 1 | April 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems, LLC | Waukesha, WI, United States | Manufacturer | 1 | August 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ischemaview, Inc. | Golden, CO, United States | Manufacturer | 1 | July 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| NEUROCAREAI INC (DBA SaveLife.AI) | Prosper, TX, United States | Manufacturer | 1 | May 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Riverain Technologies | Miamisburg, OH, United States | Manufacturer | 1 | March 10, 2022 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.