510(k) Report

FDA applicant

Brotherston/Pxi

Pennsauken, NJ2 decisions1992–19920 recalls

FDA records 2 decisions for Brotherston/Pxi (Pennsauken, NJ) in 1992: 2 510(k) clearances. Most are in product codes IZG (System, X-Ray, Photofluorographic) and KPR (System, X-Ray, Stationary). 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 Brotherston/Pxi’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Brotherston/Pxi since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Brotherston/Pxi 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?

  • IZGSystem, X-Ray, Photofluorographic1decision
  • KPRSystem, X-Ray, Stationary1decision

What has FDA decided for it lately?

  • K913436Pxi Pneumatic Compression PaddleBrotherston/Pxi · 1992
  • K913435Pxi UrcdBrotherston/Pxi · 1992

All 2 as Brotherston/Pxi →