FDA applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
FDA records 15 decisions for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Wauwatosa, WI) from 2016 to 2026: 15 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and KGI (Densitometer, Bone). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 34 predicates, 3 of them its own earlier devices. 13 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
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