Medical Device Manufacturer · US , Wauwatosa , WI

GE Medical Systems Ultrasound and Primary Care Diagnostics - FDA 510(...

65 submissions · 65 cleared · Since 2015

Recent clearances: LOGIQ e, LOGIQ Vita, LOGIQ Totus

65

Total

65

Cleared

0

Denied

FDA 510(k) Regulatory Record - GE Medical Systems Ultrasound and Primary Care Diagnostics Radiology ✕

65 devices

1-12 of 65

Cleared May 26, 2026

Radiology · 109d

Cleared Mar 24, 2026

Radiology · 22d

Cleared Jan 08, 2026

Radiology · 100d

Cleared Jan 07, 2026

Radiology · 99d

Cleared Nov 24, 2025

Voluson Expert 18

Radiology · 122d

Cleared Oct 29, 2025

Radiology · 125d

Cleared Oct 29, 2025

Radiology · 124d

Cleared Jul 25, 2025

Radiology · 87d

Cleared Jul 16, 2025

EchoPAC Software Only / EchoPAC Plug-in

Radiology · 77d

Cleared Jul 10, 2025

Radiology · 86d

Cleared May 29, 2025

Voluson™ Performance 16

Radiology · 94d

Cleared May 01, 2025

Radiology · 107d

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