Medical Device Manufacturer · US , Wauwatosa , WI

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

14 submissions · 14 cleared · Since 2016

Total

Cleared

Denied

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC has 14 FDA 510(k) cleared radiology devices. Based in Wauwatosa, US.

Latest FDA clearance: Apr 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.

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

14 devices

1-14 of 14

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

LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3

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

Filters