510(k) Report

FDA applicant

Positron

Houston, TX5 decisions1981–20020 recalls

FDA records 5 decisions for Positron (Houston, TX) from 1981 to 2002: 5 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and EWO (Audiometer). No recall is linked to its devices.

FDA’s records also spell it “Positron Corp.”.

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 Positron’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Positron since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Positron 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?

  • KPSSystem, Tomography, Computed, Emission4decisions
  • EWOAudiometer1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K022001Mpower, Model 712 SeriesPositron Corp. · 20022cite it

What has FDA decided for it lately?

  • K022001Mpower, Model 712 SeriesPositron Corp. · 2002
  • K926206Posicam-HZ & Posicam-HZLPositron · 1993
  • K911275Posicam System Model 6.5 Posicam-HZ SystemPositron · 1991
  • K894998Modified Posicam System Model 6.5Positron · 1989
  • K810537Automatic Screening AudiometerPositron · 1981

All 4 as Positron →The one decision as Positron Corp. →