FDA applicant
GE Medical Systems
FDA records 330 decisions for GE Medical Systems (Waukesha, WI) from 1988 to 2026: 329 510(k) clearances and 1 original PMA approval. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 281 predicates, 180 of them its own earlier devices. 413 recalls are linked to its devices, 5 Class I.
FDA’s records also spell it “Ge Medical Systems, LLC”, “Ge Medical Systems, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided GE Medical Systems’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
11in 2026
Class I Class II/III not classified
Planning a device like GE Medical Systems’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