ClearanceBrief
Company ยท US

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.

15510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic8
KGIDensitometer, Bone4
LLZSystem, Image Processing, Radiological1
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer1
QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 2, 2026K261042Lung Guidance
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
QJU
Apr 20, 2026K252718Lunar Astra
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
KGI
Mar 27, 2026K254161Automated Aortic Stenosis Software (AutoAS)
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
POK
Jul 18, 2022K221148Vivid iq
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Jan 15, 2021K203677ViewPoint 6
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
LLZ
Apr 17, 2020K200158LOGIQ E10
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Sep 19, 2019K191112GEHC DXA Bone Densitometers with enCORE version 18
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
KGI
Nov 6, 2018K181934Vivid T8, Vivid T9
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Apr 20, 2018K180782Aria
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
KGI
Jun 21, 2017K170714Venue
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Jun 14, 2017K170878Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Dec 2, 2016K161682GE Lunar DXA Bone Densitometers with enCORE version 17
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
KGI
Aug 31, 2016K161588Vscan Extend
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Aug 5, 2016K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Jan 4, 2016K153037LOGIQ V1/ LOGIQ V2
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN

Latest recalls

DateFirm and productCodeLinked 510(k)
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