GE Medical Systems Ultrasound and Primary Care Diagnostics - FDA 510(...
Recent clearances: EchoPAC Software Only / EchoPAC Plug-in (v211), Vivid Explorer/Vivid Advanced/Vivid Focus, LOGIQ Focus
68
Total
68
Cleared
0
Denied
FDA 510(k) Regulatory Record - GE Medical Systems Ultrasound and Primary Care Diagnostics Radiology ✕
68 devices
Cleared
Sep 16, 2026
EchoPAC Software Only / EchoPAC Plug-in (v211)
Radiology
124d
Cleared
Sep 02, 2026
Vivid Explorer/Vivid Advanced/Vivid Focus
Radiology
134d
Cleared
Jul 30, 2026
LOGIQ Focus
Radiology
58d
Cleared
May 26, 2026
LOGIQ e
Radiology
109d
Cleared
Mar 24, 2026
LOGIQ Vita
Radiology
22d
Cleared
Jan 08, 2026
LOGIQ Totus
Radiology
100d
Cleared
Jan 07, 2026
LOGIQ Fortis
Radiology
99d
Cleared
Nov 24, 2025
Voluson Expert 18
Radiology
122d
Cleared
Oct 29, 2025
LOGIQ E10s
Radiology
125d
Cleared
Oct 29, 2025
LOGIQ E10
Radiology
124d
Cleared
Jul 25, 2025
Venue
Radiology
87d
Cleared
Jul 16, 2025
EchoPAC Software Only / EchoPAC Plug-in
Radiology
77d
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