510(k) Report

FDA applicant

Avant Medical Systems

Deer Field, IL1 decision2005–20050 recalls

FDA records 1 decision for Avant Medical Systems (Deer Field, IL) in 2005: 1 510(k) clearance. All are in product code KPR (System, X-Ray, Stationary). Its devices cite 1 predicate, 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 Avant Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Avant Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Avant Medical Systems 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?

  • KPRSystem, X-Ray, Stationary1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K052541Model HF-50R Computer Controlled X-Ray SystemAvant Medical Systems · 20051cites it

What has FDA decided for it lately?

  • K052541Model HF-50R Computer Controlled X-Ray SystemAvant Medical Systems · 2005

The one decision as Avant Medical Systems →

Other applicant names beginning “Avant”

FDA records each applicant name separately; these may or may not be the same firm.

Avant Wellness Systems, LLC 1Avant Medical Corporation 1