Ge Healthcare - FDA 510(k) Cleared Devices
GE HealthCare is an American multinational medical technology company headquartered in Waukesha, US. The company operates globally across medical imaging, ultrasound, patient care solutions, and pharmaceutical diagnostics.
GE HealthCare has received 168 FDA 510(k) clearances from 168 total submissions since 2004. Radiology devices represent the dominant focus, accounting for 73% of regulatory submissions. The company's latest FDA 510(k) clearance was in 2026, reflecting continued innovation in medical imaging technologies.
Recent cleared devices span Radiology specialties including advanced imaging systems, ultrasound platforms, and diagnostic processing software. The company's product portfolio demonstrates expertise in computed tomography, magnetic resonance imaging, women's health screening, and X-ray systems.
Explore the complete regulatory record by reviewing individual device names, product codes, and clearance dates in the database.
FDA 510(k) cleared devices by Ge Healthcare
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