510(k) Report

FDA applicant

Radscan Medical Equipment, Inc.

Phoenix, AZ1 decision2011–20110 recalls

FDA records 1 decision for Radscan Medical Equipment, Inc. (Phoenix, AZ) in 2011: 1 510(k) clearance. All are in product code KKX (Drape, Surgical, Antimicrobial). 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, general and plastic surgery panel, where it files most

How often FDA has decided Radscan Medical Equipment, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Radscan Medical Equipment, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KKXDrape, Surgical, Antimicrobial1decision

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.

  • K101350Radscan Equipment SlickerRadscan Medical Equipment, Inc. · 20111cites it

What has FDA decided for it lately?

  • K101350Radscan Equipment SlickerRadscan Medical Equipment, Inc. · 2011

The one decision as Radscan Medical Equipment, Inc. →