Data / Medical devices / Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer / United States
FDA-registered makers of Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK). 5 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
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Product code
- POK
- Country
- United States
Makers of Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Koios Medical, Inc. | New York, NY, United States | Manufacturer | 4 | July 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ischemaview, Inc. | Golden, CO, United States | Manufacturer | 2 | January 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Avenda Health Inc. | Culver City, CA, United States | Manufacturer | 1 | November 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Waukesha, WI, United States | Manufacturer | 1 | March 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Precision Medical Ventures, Inc. Dba Revealdx | Seattle, WA, United States | Manufacturer | 1 | January 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Philips Ultrasound LLC | Reedsville, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Ultrasound LLC | Bothell, WA, United States | Complaint file establishment, Manufacturer | 0 | 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.