Medical Device Manufacturer · US , Wauwatosa , WI

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC - FDA 5...

15 submissions · 15 cleared · Since 2016

Recent clearances: Lung Guidance, Lunar Astra, Automated Aortic Stenosis Software (AutoAS)

Total

Cleared

Denied

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC has 15 FDA 510(k) cleared radiology devices. Based in Wauwatosa, US.

Latest FDA clearance: Oct 2026. Active since 2016.

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

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is one of 16073 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 & Primary Care Diagnostics, LLC

15 devices

1-12 of 15

Automated Aortic Stenosis Software (AutoAS)

GEHC DXA Bone Densitometers with enCORE version 18

Vivid S60N, Vivid S70N

K170878 · IYN

Radiology · 82d

Cleared Dec 02, 2016

GE Lunar DXA Bone Densitometers with enCORE version 17

K161682 · KGI

Radiology · 168d

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC - FDA 5...

FDA 510(k) Regulatory Record - GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

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