510(k) Report

FDA applicant

American Medical Sales, Inc.

Culver City, CA3 decisions1992–20050 recalls

FDA records 3 decisions for American Medical Sales, Inc. (Culver City, CA) from 1992 to 2005: 3 510(k) clearances. Most are in product codes IXC (Illuminator, Radiographic-Film) and IXY (Holder, Radiographic Cassette, Wall-Mounted). 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 American Medical Sales, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Medical Sales, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Medical Sales, 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?

  • IXCIlluminator, Radiographic-Film1decision
  • IXYHolder, Radiographic Cassette, Wall-Mounted1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K922079Rotolux, Selectolux, ShuttervueAmerican Medical Sales, Inc. · 19921cites it

What has FDA decided for it lately?

  • K052537Catella Diagnostic Workstation, Version 4.0American Medical Sales, Inc. · 2005
  • K930230Radiographic Wall-Mounted Cassette HolderAmerican Medical Sales, Inc. · 1993
  • K922079Rotolux, Selectolux, ShuttervueAmerican Medical Sales, Inc. · 1992

All 3 as American Medical Sales, Inc. →