Medical Device Manufacturer · US , Wauwatosa , WI

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

68 submissions · 68 cleared · Since 2015

Recent clearances: EchoPAC Software Only / EchoPAC Plug-in (v211), Vivid Explorer/Vivid Advanced/Vivid Focus, LOGIQ Focus

View 68 510(k) Devices ↓

Total

Cleared

Denied

GE Medical Systems Ultrasound and Primary Care Diagnostics has 68 FDA 510(k) cleared radiology devices. Based in Wauwatosa, US.

Latest FDA clearance: Sep 2026. Active since 2015.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

GE Medical Systems Ultrasound and Primary Care Diagnostics is one of 26109 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

68 devices

1-12 of 68

Cleared Sep 16, 2026

EchoPAC Software Only / EchoPAC Plug-in (v211)

K261623 · QIH

Radiology · 124d

Cleared Sep 02, 2026

Vivid Explorer/Vivid Advanced/Vivid Focus

EchoPAC Software Only / EchoPAC Plug-in

K251342 · QIH

Radiology · 77d

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

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

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