Data / Medical devices / Computer, Diagnostic, Pre-Programmed, Single-Function

Computer, Diagnostic, Pre-Programmed, Single-Function (DXG): 45 FDA-registered makers in 13 countries

45 establishments in 13 countries are registered with the FDA to make Computer, Diagnostic, Pre-Programmed, Single-Function (product code DXG, Class 2, 21 CFR 870.1435). 15 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 177 510(k) clearances under this code, the latest on February 13, 2026, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

DXG

Device class

2

Regulation

870.1435

Medical specialty

Cardiovascular

Makers by country

Makers of Computer, Diagnostic, Pre-Programmed, Single-Function

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 February 13, 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.