FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

710 results for "GE Medical Systems"
145–168 of 710
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared Aug 09, 2019
Versana Balance
K191792 · IYN
GE Medical Systems Ultrasound and...
Radiology · 37d
Cleared Jul 26, 2019
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex...
K191777 · JAK
Ge Medical Systems, LLC
Radiology · 24d
Cleared Apr 12, 2019
Deep Learning Image Reconstruction
K183202 · JAK
Ge Medical Systems, LLC
Radiology · 144d
Cleared Apr 08, 2019
Bone VCAR (BVCAR)
K183204 · JAK
GE Medical Systems SCS
Radiology · 140d
Cleared Mar 29, 2019
Thoracic VCAR with GSI Pulmonary Perfusion
K183210 · LLZ
GE Medical Systems SCS
Radiology · 130d
Cleared Feb 13, 2019
SnapShot Freeze 2
K183161 · JAK
Ge Medical Systems, LLC
Radiology · 90d
Cleared Jan 28, 2019
Venue GO
K183362 · IYN
GE Medical Systems Ultrasound and...
Radiology · 55d
Cleared Jan 18, 2019
SIGNA Premier
K183231 · LNH
Ge Medical Systems, LLC
Radiology · 59d
Cleared Dec 21, 2018
4D View
K182750 · LLZ
GE Medical Systems Ultrasound and...
Radiology · 84d
Cleared Dec 06, 2018
Vivid iq
K181727 · IYN
GE Medical Systems Ultrasound and...
Radiology · 160d
Cleared Nov 21, 2018
Versana Premier
K182277 · IYN
GE Medical Systems Ultrasound and...
Radiology · 91d
Cleared Nov 06, 2018
Vivid T8, Vivid T9
K181934 · IYN
GE Medical Systems Ultrasound &...
Radiology · 110d
Cleared Oct 25, 2018
Vivid E80, Vivid E90, Vivid E95
K181685 · IYN
GE Medical Systems Ultrasound and...
Radiology · 121d
Cleared Oct 19, 2018
Vivid S60N, Vivid S70N
K182450 · IYN
GE Medical Systems Ultrasound and...
Radiology · 42d
Cleared Sep 18, 2018
MAC VU360 Resting ECG Analysis System
K173830 · DPS
Ge Medical Systems Information...
Cardiovascular · 274d
Cleared Sep 06, 2018
Optima XR240amx
K182234 · IZL
Ge Medical Systems, LLC
Radiology · 20d
Cleared Jun 25, 2018
Vscan Extend
K180995 · IYN
GE Medical Systems Ultrasound and...
Radiology · 70d
Cleared May 02, 2018
Venue
K180599 · IYN
GE Medical Systems Ultrasound and...
Radiology · 56d
Cleared Apr 24, 2018
GSI Viewer with GSI Fat Option
K180225 · JAK
GE Medical Systems SCS
Radiology · 88d
Cleared Apr 20, 2018
Aria
K180782 · KGI
GE Medical Systems Ultrasound &...
Radiology · 25d
Cleared Apr 11, 2018
PET Digital Gating
K180318 · KPS
Ge Medical Systems, LLC
Radiology · 65d
Cleared Jan 12, 2018
Optima XR240amx, AutoGrid
K173602 · IZL
Ge Medical Systems, LLC
Radiology · 52d
Cleared Jan 05, 2018
ViewPoint 6
K173456 · LLZ
Ge Medical Systems Ultrasound and...
Radiology · 59d
Cleared Nov 02, 2017
Vivid E80, Vivid E90, Vivid E95
K173341 · IYN
GE Medical Systems
Radiology · 9d