Data / Medical devices / System, X-Ray, Fluoroscopic, Image-Intensified

System, X-Ray, Fluoroscopic, Image-Intensified (JAA): 91 FDA-registered makers in 17 countries

91 establishments in 17 countries are registered with the FDA to make System, X-Ray, Fluoroscopic, Image-Intensified (product code JAA, Class 2, 21 CFR 892.1650). 30 of them have a 510(k) clearance or PMA approval on file and 10 have a recall event. The FDA has issued 300 510(k) clearances under this code, the latest on May 29, 2026, and lists 132 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code

JAA

Device class

2

Regulation

892.1650

Medical specialty

Radiology

Makers by country

Makers of System, X-Ray, Fluoroscopic, Image-Intensified

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 May 29, 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.