510(k) Report

FDA applicant

Ohio Imaging, Inc.

Cleveland, OH3 decisions1988–19951 recall

FDA records 3 decisions for Ohio Imaging, Inc. (Cleveland, OH) from 1988 to 1995: 3 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYX (Camera, Scintillation (Gamma)). 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 Ohio Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ohio Imaging, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ohio Imaging, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Ohio”

FDA records each applicant name separately; these may or may not be the same firm.