Data / Medical devices / System, Image Processing, Radiological

System, Image Processing, Radiological (LLZ): 551 FDA-registered makers in 37 countries

551 establishments in 37 countries are registered with the FDA to make System, Image Processing, Radiological (product code LLZ, Class 2, 21 CFR 892.2050). 411 of them have a 510(k) clearance or PMA approval on file and 47 have a recall event. The FDA has issued 2,295 510(k) clearances under this code, the latest on October 21, 2026, and lists 433 recall events (3 Class I). FDA data exported November 3, 2026.

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Product code

LLZ

Device class

2

Regulation

892.2050

Medical specialty

Radiology

Makers by country

Makers of System, Image Processing, Radiological

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 21, 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.