510(k) Report

FDA applicant

Applied X-Ray Technologies, Inc.

Denver, CO3 decisions1988–19970 recalls

FDA records 3 decisions for Applied X-Ray Technologies, Inc. (Denver, CO) from 1988 to 1997: 3 510(k) clearances. Most are in product codes IXL (Device, Spot-Film) and IZX (Collimator, Manual, Radiographic). 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 Applied X-Ray Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied X-Ray Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Applied X-Ray Technologies, 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?

  • IXLDevice, Spot-Film2decisions
  • IZXCollimator, Manual, Radiographic1decision

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.

  • K972966Axt 150M Manual Collimator (Axt 150M)Applied X-Ray Technologies, Inc. · 19971cites it

What has FDA decided for it lately?

  • K972966Axt 150M Manual Collimator (Axt 150M)Applied X-Ray Technologies, Inc. · 1997
  • K942367Axt 1400 Spotfilm DeviceApplied X-Ray Technologies, Inc. · 1994
  • K882492A.X.T. Spotfilm DeviceApplied X-Ray Technologies, Inc. · 1988

All 3 as Applied X-Ray Technologies, Inc. →