FDA applicant
General Electric Medical Systems
FDA records 6 decisions for General Electric Medical Systems (Waukesha, WI) from 2001 to 2005: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 7 predicates, 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
How often FDA has decided General Electric Medical Systems’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for General Electric Medical Systems since 2007.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like General Electric 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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