510(k) Report

FDA applicant

Gvi Technology Partners

Twinsburg, OH3 decisions2003–20071 recall

FDA records 3 decisions for Gvi Technology Partners (Twinsburg, OH) from 2003 to 2007: 3 510(k) clearances. Most are in product codes IYX (Camera, Scintillation (Gamma)) and KPS (System, Tomography, Computed, Emission). Its devices cite 4 predicates, 2 of them its own earlier devices. 1 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 Gvi Technology Partners’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gvi Technology Partners 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?

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

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K023373Onepass Nuclear Imaging System, Model 70-500101Gvi Technology Partners · 20032cite it

What has FDA decided for it lately?

  • K072191Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners · 2007
  • K051402Onepass Nuclear Medicine Imaging SystemGvi Technology Partners · 2005
  • K023373Onepass Nuclear Imaging System, Model 70-500101Gvi Technology Partners · 20031 recall

All 3 as Gvi Technology Partners →

What has been recalled?

1 recall linked to its devices; the latest:

  • K023373CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with…Jan 16, 2004