510(k) Report

FDA applicant

Oec Medical Systems, Inc.

Salt Lake City, UT1 decision2017–20174 recalls

FDA records 1 decision for Oec Medical Systems, Inc. (Salt Lake City, UT) in 2017: 1 510(k) clearance. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 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 Oec Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2025

2021: 12023: 12024: 12025: 1
2017high 1 (2021) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Oec Medical Systems, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K170752OEC EliteOec Medical Systems, Inc. · 20171cites it

What has FDA decided for it lately?

  • K170752OEC EliteOec Medical Systems, Inc. · 20174 recalls

The one decision as Oec Medical Systems, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K170752OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital…Mar 21, 2025Class II
  • K170752OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile…Nov 21, 2024Class II
  • K192819OEC Elite Systems with 9-inch Image IntensifierMay 15, 2023Class II
  • K172550OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital…Jun 10, 2021Class II