510(k) Report

FDA applicant

Ge Healthcare Surgery GE Oec Medical Systems, Inc.

Salt Lake City, UT3 decisions2012–201312 recalls

FDA records 3 decisions for Ge Healthcare Surgery GE Oec Medical Systems, Inc. (Salt Lake City, UT) from 2012 to 2013: 3 510(k) clearances. Most are in product codes OXO (Image-Intensified Fluoroscopic X-Ray System…) and OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 3 predicates, 1 of them its own earlier devices. 12 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 Ge Healthcare Surgery GE Oec Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2012: 22013: 1
2012high 2 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2025

2013: 12014: 32016: 32020: 12023: 22024: 12025: 1
2012high 3 (2014) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare Surgery GE Oec Medical Systems, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2decisions
  • OWBInterventional Fluoroscopic X-Ray System1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K120613Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 20123cite it
  • K122234Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 20122cite it
  • K123603Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 PrimeGe Healthcare Surgery GE Oec Medical Systems, Inc. · 20131cites it

What has FDA decided for it lately?

  • K123603Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 PrimeGe Healthcare Surgery GE Oec Medical Systems, Inc. · 20135 recalls
  • K122234Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 20126 recalls
  • K120613Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 20127 recalls

All 3 as Ge Healthcare Surgery GE Oec Medical Systems, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K073543GE HealthCare OEC 9900 Elite C-arm Systems.Jul 2, 2025Class II
  • K120613OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite…Nov 21, 2024Class II
  • K073543OEC 9900 Systems with 9-inch Image IntensifierMay 15, 2023Class II
  • K073543Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE…May 15, 2023Class II
  • K111551The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the…May 8, 2020Class II
  • K120613OEC 9900 Elite. MDL Numbers: D148942, D155043Dec 27, 2016Class II