510(k) Report

FDA applicant

Strichman Medical Equipment, Inc.

Medfield, MA3 decisions1991–19930 recalls

FDA records 3 decisions for Strichman Medical Equipment, Inc. (Medfield, MA) from 1991 to 1993: 3 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYX (Camera, Scintillation (Gamma)). 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 Strichman Medical Equipment, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Strichman Medical Equipment, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Strichman Medical Equipment, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Strichman Medical Equipment, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission2decisions
  • IYXCamera, Scintillation (Gamma)1decision

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.

  • K923736Gamma 600TStrichman Medical Equipment, Inc. · 19921cites it

What has FDA decided for it lately?

  • K925186Equilibrium Radionuclide Angiocardioraphy AnalysisStrichman Medical Equipment, Inc. · 1993
  • K923736Gamma 600TStrichman Medical Equipment, Inc. · 1992
  • K903469Gamma 600 Nuclear Medicine ComputerStrichman Medical Equipment, Inc. · 1991

All 3 as Strichman Medical Equipment, Inc. →