510(k) Report

FDA applicant

Eradlink, Inc.

Torrance, CA2 decisions2002–20050 recalls

FDA records 2 decisions for Eradlink, Inc. (Torrance, CA) from 2002 to 2005: 2 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LMA (Digitizer, Image, Radiological). Its devices cite 3 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 Eradlink, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eradlink, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eradlink, Inc. 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?

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

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K020243Laserpro 16Eradlink, Inc. · 20022cite it
  • K052938CR-PROEradlink, Inc. · 20051cites it

What has FDA decided for it lately?

  • K052938CR-PROEradlink, Inc. · 2005
  • K020243Laserpro 16Eradlink, Inc. · 2002

All 2 as Eradlink, Inc. →