510(k) Report

FDA applicant

Digital Healthcare, Ltd.

Wake Forest, NC1 decision2007–20070 recalls

FDA records 1 decision for Digital Healthcare, Ltd. (Wake Forest, NC) in 2007: 1 510(k) clearance. All are in product code NFJ (System, Image Management, Ophthalmic). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Digital Healthcare, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Digital Healthcare, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NFJSystem, Image Management, Ophthalmic1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071299IP System, Oculab IP, Optomize IP, Retasure IPDigital Healthcare, Ltd. · 20072cite it

What has FDA decided for it lately?

  • K071299IP System, Oculab IP, Optomize IP, Retasure IPDigital Healthcare, Ltd. · 2007

The one decision as Digital Healthcare, Ltd. →