510(k) Report

FDA applicant

Advantech

Wakefield, MA3 decisions1990–19900 recalls

FDA records 3 decisions for Advantech (Wakefield, MA) in 1990: 3 510(k) clearances. Most are in product codes IZX (Collimator, Manual, Radiographic) and ITY (Assembly, Tube Housing, X-Ray, Diagnostic). 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 Advantech’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advantech since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advantech 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?

  • IZXCollimator, Manual, Radiographic2decisions
  • ITYAssembly, Tube Housing, X-Ray, Diagnostic1decision

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.

  • K904182R-800-SFAdvantech · 19901cites it

What has FDA decided for it lately?

  • K904182R-800-SFAdvantech · 1990
  • K900007R-100-ET Manual CollimatorAdvantech · 1990
  • K896486R-150-ET CollimatorAdvantech · 1990

All 3 as Advantech →