Data / Medical devices / System, Image Management, Ophthalmic

System, Image Management, Ophthalmic (NFJ): 31 FDA-registered makers in 9 countries

31 establishments in 9 countries are registered with the FDA to make System, Image Management, Ophthalmic (product code NFJ, Class 2, 21 CFR 892.2050). 27 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 53 510(k) clearances under this code, the latest on July 17, 2026, and lists 13 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

NFJ

Device class

2

Regulation

892.2050

Medical specialty

Radiology

Makers by country

Makers of System, Image Management, Ophthalmic

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 July 17, 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.