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)

15

Total

15

Cleared

0

Denied

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

15 devices

1-15 of 15

Cleared Oct 02, 2026

Radiology · 185d

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

Cleared Aug 05, 2016

LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3

Radiology · 98d

Cleared Jan 04, 2016

LOGIQ V1/ LOGIQ V2

Radiology · 77d