Data / Medical devices / Transducer, Ultrasonic, Diagnostic

Transducer, Ultrasonic, Diagnostic (ITX): 272 FDA-registered makers in 31 countries

272 establishments in 31 countries are registered with the FDA to make Transducer, Ultrasonic, Diagnostic (product code ITX, Class 2, 21 CFR 892.1570). 81 of them have a 510(k) clearance or PMA approval on file and 13 have a recall event. The FDA has issued 415 510(k) clearances under this code, the latest on September 24, 2026, and lists 59 recall events (11 Class I). FDA data exported November 2, 2026.

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Product code

ITX

Device class

2

Regulation

892.1570

Medical specialty

Radiology

Makers by country

Makers of Transducer, Ultrasonic, Diagnostic

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 September 24, 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.