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Data / Medical devices / Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer (POK): 16 FDA-registered makers in 6 countries

16 establishments in 6 countries are registered with the FDA to make Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK, Class 2, 21 CFR 892.2060). 14 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on October 23, 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
POK
Device class
2
Regulation
892.2060
Medical specialty
Radiology

Makers by country

CountryMakers
United States7
United Kingdom3
France3
Israel1
Canada1
Australia1

Makers of Computer-Assisted Diagnostic 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Koios Medical, Inc.New York, NY, United StatesManufacturer4July 2, 2026000api.fda.gov
Brainomix LimitedOxford Oxfordshire, United KingdomComplaint file establishment, Manufacturer2February 14, 2025000api.fda.gov
Ischemaview, Inc.Golden, CO, United StatesManufacturer2January 19, 2024000api.fda.gov
SonioParis, FranceComplaint file establishment, Manufacturer2June 4, 2026000api.fda.gov
Aisap LtdRamat Gan Central, IsraelManufacturer1August 1, 2024000api.fda.gov
Avenda Health Inc.Culver City, CA, United StatesManufacturer1November 22, 2022000api.fda.gov
Avicenna.aiLa Ciotat Bouches-du-Rhone, FranceManufacturer1March 15, 2024000api.fda.gov
Brightheart SASParis, FranceManufacturer1November 14, 2024000api.fda.gov
Circle Cardiovascular Imaging IncCalgary Alberta, CanadaManufacturer1July 1, 2025000api.fda.gov
Echoiq LimitedSydney New South Wales, AustraliaManufacturer1October 4, 2024000api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLCWaukesha, WI, United StatesManufacturer1March 27, 2026000api.fda.gov
Optellum LtdOxford Oxfordshire, United KingdomComplaint file establishment, Manufacturer1March 5, 2021000api.fda.gov
Precision Medical Ventures, Inc. Dba RevealdxSeattle, WA, United StatesManufacturer1January 30, 2026000api.fda.gov
Ultromics, Ltd.Oxford Oxfordshire, United KingdomComplaint file establishment, Manufacturer1December 18, 2020000api.fda.gov
Philips Ultrasound LLCReedsville, PA, United StatesManufacturer0000api.fda.gov
Philips Ultrasound LLCBothell, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated October 23, 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.