FDA applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA records 70 decisions for GE Medical Systems Ultrasound and Primary Care Diagnostics (Wauwatosa, WI) from 2015 to 2026: 70 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 99 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 123 predicates, 60 of them its own earlier devices. 22 recalls are linked to its devices.
FDA’s records also spell it “GE Medical Systems Ultrasound and Primary care Diagnostics, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided GE Medical Systems Ultrasound and Primary Care Diagnostics’s devices, and how often a recall has named them.
FDA decisions per year
10in 2025
2026 so far, outlined.
Recalls per year
7in 2025
Class I Class II/III not classified
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