Data / Medical devices / Automated Radiological Image Processing Software

Automated Radiological Image Processing Software (QIH): 210 FDA-registered makers in 32 countries

210 establishments in 32 countries are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH, Class 2, 21 CFR 892.2050). 150 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 338 510(k) clearances under this code, the latest on October 19, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

QIH

Device class

2

Regulation

892.2050

Medical specialty

Radiology

Makers by country

Makers of Automated Radiological Image Processing Software

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.

Updated October 19, 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.