510(k) Report

FDA applicant

Trionix Research Laboratory, Inc.

Twinsburg, OH16 decisions1988–19971 recall

FDA records 16 decisions for Trionix Research Laboratory, Inc. (Twinsburg, OH) from 1988 to 1997: 16 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 3 predicates, 3 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 Trionix Research Laboratory, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trionix Research Laboratory, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Trionix Research Laboratory, Inc. 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, Emission16decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K920776Cardiac Triad Nuclear Imaging SystemTrionix Research Laboratory, Inc. · 19921cites it
  • K873775Triad Nuclear Imaging SystemTrionix Research Laboratory, Inc. · 19881cites it
  • K923345Biad New Detector OptionTrionix Research Laboratory, Inc. · 19921cites it

What has FDA decided for it lately?

  • K964438511 Kev CollimatorTrionix Research Laboratory, Inc. · 1997
  • K962481Quasar Recovery Imaging PackageTrionix Research Laboratory, Inc. · 1996
  • K964268Triad 88 Nuclear Imaging SystemTrionix Research Laboratory, Inc. · 1996
  • K964265Cardiac Triad Nuclear Imaging Single Photon Emission Computed Tomography SystemTrionix Research Laboratory, Inc. · 1996
  • K964267Monad Nuclear Imaging Single Photon Emission Computed Tomography SystemTrionix Research Laboratory, Inc. · 1996
  • K964266Biad Nuclear Imaging SystemTrionix Research Laboratory, Inc. · 1996
  • K961597Gated Mibi 3-D Ejection Fraction ProcessingTrionix Research Laboratory, Inc. · 1996
  • K923151Cardiac Triad New Detector OptionTrionix Research Laboratory, Inc. · 1992

All 16 as Trionix Research Laboratory, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K892875BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad…Aug 1, 2006