510(k) Report

FDA applicant

Advanced Radiation Measurements, Inc.

Port St. Lucie, FL1 decision1994–19940 recalls

FDA records 1 decision for Advanced Radiation Measurements, Inc. (Port St. Lucie, FL) in 1994: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). 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 Advanced Radiation Measurements, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Radiation Measurements, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Radiation Measurements, 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?

  • IYEAccelerator, Linear, Medical1decision

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.

  • K933558Arm Radiation Beam ScannerAdvanced Radiation Measurements, Inc. · 19941cites it

What has FDA decided for it lately?

  • K933558Arm Radiation Beam ScannerAdvanced Radiation Measurements, Inc. · 1994

The one decision as Advanced Radiation Measurements, Inc. →