Ge Medical Systems, LLC - FDA 510(k) Cleared Devices

Ge Medical Systems, LLC is a medical device manufacturer based in Waukesha, US. The company specializes in Radiology devices and solutions.

GE Medical Systems has received 105 FDA 510(k) clearances from 105 total submissions. The company's regulatory focus is entirely on Radiology devices, with a clearance history spanning from 2003 to 2026. The latest clearance in 2026 demonstrates active regulatory engagement within the past two years.

Recent cleared devices include advanced imaging systems such as the Photonova Spectra series, SIGNA™ product line, AIR Recon DL, Revolution Vibe, and Sonic DL. These products reflect the company's emphasis on magnetic resonance imaging, computed tomography, and AI-enhanced diagnostic imaging technologies.

Explore the complete regulatory record, including device names, product codes, and clearance dates, to review GE Medical Systems' full FDA 510(k) submission history.

Regulatory submissions have been managed by Intertek Testing Services, Tuv Rheinland of North America, Inc. and GE Healthcare. 3 devices have linked clinical trials registered on ClinicalTrials.gov.