510(k) Report

FDA applicant

Radlink, Inc.

El Sugundo, CA2 decisions2014–20250 recalls

FDA records 2 decisions for Radlink, Inc. (El Sugundo, CA) from 2014 to 2025: 2 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LLZ (System, Image Processing, Radiological). Its devices cite 5 predicates, 1 of them its own earlier devices. 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 Radlink, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 12025: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Radlink, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142718Radlink GPSRadlink, Inc. · 20141cites it

What has FDA decided for it lately?

  • K242161Radlink GPS Pro ImagingRadlink, Inc. · 2025
  • K142718Radlink GPSRadlink, Inc. · 2014

All 2 as Radlink, Inc. →