FDA applicant
Ge Oec Medical Systems, Inc.
FDA records 18 decisions for Ge Oec Medical Systems, Inc. (Salt Lake City, UT) from 2001 to 2024: 18 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and OXO (Image-Intensified Fluoroscopic X-Ray System…). Since 2016 its 510(k)s took a median of 72 days from receipt to decision, against 76 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 13 of them its own earlier devices. 67 recalls are linked to its devices, 2 Class I.
FDA’s records also spell it “Ge Oec Medical Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ge Oec Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
4in 2025
Class I Class II/III not classified
Planning a device like Ge Oec Medical Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report