Medical Device Manufacturer · US , Wauwatosa , WI

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

14 submissions · 14 cleared · Since 2016

Recent clearances: Lunar Astra, Automated Aortic Stenosis Software (AutoAS), Vivid iq

14

Total

14

Cleared

0

Denied

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

14 devices

1-12 of 14

Cleared Apr 20, 2026

Radiology · 235d

Cleared Mar 27, 2026

Automated Aortic Stenosis Software (AutoAS)

Radiology · 95d

Cleared Jul 18, 2022

Radiology · 89d

Cleared Jan 15, 2021

Radiology · 29d

Cleared Apr 17, 2020

Radiology · 86d

Cleared Sep 19, 2019

GEHC DXA Bone Densitometers with enCORE version 18

Radiology · 146d

Cleared Nov 06, 2018

Vivid T8, Vivid T9

Radiology · 110d

Cleared Apr 20, 2018

Radiology · 25d

Cleared Jun 21, 2017

Radiology · 104d

Cleared Jun 14, 2017

Vivid S60N, Vivid S70N

Radiology · 82d

Cleared Dec 02, 2016

GE Lunar DXA Bone Densitometers with enCORE version 17

Radiology · 168d

Cleared Aug 31, 2016

Radiology · 84d