FDA applicant

Summit Nuclear

Twinsburg, OH6 decisions1991–19942 recalls

FDA records 6 decisions for Summit Nuclear (Twinsburg, OH) from 1991 to 1994: 6 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYX (Camera, Scintillation (Gamma)). 2 recalls are 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 Summit Nuclear’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Summit Nuclear since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Summit”

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

Summit Medical, Inc. 14 Summit World Trade Corp. 10 Summit Industries, Inc. 8 Summit Doppler Systems, Inc. 7 Summit Technology, Inc. 5 Summit Glove, Inc. 5 Summit Medical Products, Inc. 4 Summit Optics, Inc. 2 Summit Spine 2 Summit Medventures 2 Summit Durable Medical Equipment, Inc. 1 Summit TO Sea 1

Summit Nuclear

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Summit”