FDA applicant
Ge Dec Medical Systems
FDA records 10 decisions for Ge Dec Medical Systems (Salt Lake City, UT) from 1994 to 2000: 10 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Its devices cite 3 predicates, 1 of them its own earlier devices. 24 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ge Dec Medical Systems’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ge Dec Medical Systems since 2007.
Recalls per year
3in 2016
Class I Class II/III not classified
Planning a device like Ge Dec Medical Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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