510(k) Report

FDA applicant

General Equipment For Medical Imaging (Oncovision-

Valencia, ES3 decisions2014–20160 recalls

FDA records 3 decisions for General Equipment For Medical Imaging (Oncovision- (Valencia, ES) from 2014 to 2016: 3 510(k) clearances. Most are in product codes IYX (Camera, Scintillation (Gamma)) and KPS (System, Tomography, Computed, Emission). Its devices cite 1 predicate, 1 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 General Equipment For Medical Imaging (Oncovision-’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 22016: 1
2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — General Equipment For Medical Imaging (Oncovision- by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYXCamera, Scintillation (Gamma)2decisions
  • KPSSystem, Tomography, Computed, Emission1decision

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K140996MAMMIGeneral Equipment For Medical Imaging (Oncovision- · 20141cites it
  • K143156Sentinella 102; Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision- · 20141cites it

What has FDA decided for it lately?

  • K162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision- · 2016
  • K143156Sentinella 102; Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision- · 2014
  • K140996MAMMIGeneral Equipment For Medical Imaging (Oncovision- · 2014

All 3 as General Equipment For Medical Imaging (Oncovision- →