Data / Medical devices / System, Imaging, Pulsed Echo, Ultrasonic

System, Imaging, Pulsed Echo, Ultrasonic (IYO): 243 FDA-registered makers in 24 countries

243 establishments in 24 countries are registered with the FDA to make System, Imaging, Pulsed Echo, Ultrasonic (product code IYO, Class 2, 21 CFR 892.1560). 110 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 897 510(k) clearances under this code, the latest on October 20, 2026, and lists 51 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

IYO

Device class

2

Regulation

892.1560

Medical specialty

Radiology

Makers by country

Makers of System, Imaging, Pulsed Echo, Ultrasonic

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 20, 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.