510(k) Report

FDA applicant

Gammex, Inc.

Middleton, WI3 decisions1995–20150 recalls

FDA records 3 decisions for Gammex, Inc. (Middleton, WI) from 1995 to 2015: 3 510(k) clearances. Most are in product codes LMD (System, Digital Image Communications…) and IYE (Accelerator, Linear, Medical). Its devices cite 3 predicates, 0 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 Gammex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gammex, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LMDSystem, Digital Image Communications, Radiological1decision
  • IYEAccelerator, Linear, Medical1decision
  • IWEMonitor, Patient Position, Light-Beam1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K152303CT Sim Laser SystemGammex, Inc. · 2015
  • K954564Pid-1 Precision Intelligent DosimeterGammex, Inc. · 1996
  • K953514Courier IIGammex, Inc. · 1995

All 3 as Gammex, Inc. →