FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

719 results for "GE Medical Systems"
73–96 of 719
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared May 25, 2023
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care...
K223491 · QBS
Ge Medical Systems, LLC
Radiology · 185d
Cleared May 04, 2023
Auto Segmentation
K230082 · QKB
Ge Medical Systems, LLC
Radiology · 113d
Cleared Mar 21, 2023
FlightPlan for Embolization
K223490 · LLZ
GE Medical Systems SCS
Radiology · 120d
Cleared Mar 14, 2023
ONE-CUF
K230145 · DXQ
Ge Medical Systems Information...
Cardiovascular · 55d
Cleared Mar 09, 2023
Spectral Bone Marrow
K223514 · JAK
Ge Medical Systems, LLC
Radiology · 107d
Cleared Feb 15, 2023
Versana Essential
K223407 · IYN
GE Medical Systems Ultrasound and...
Radiology · 98d
Cleared Dec 21, 2022
Mural Clinical Viewer
K222586 · MHX
Ge Medical Systems Information...
Cardiovascular · 117d
Cleared Dec 20, 2022
EK12 V2 Algorithm
K221904 · MHX
Ge Medical Systems Information...
Cardiovascular · 173d
Cleared Nov 22, 2022
Vision 2, EVARVision, TrackVision 2, HeartVision 2
K223152 · LLZ
GE Medical Systems SCS
Radiology · 47d
Cleared Nov 22, 2022
DynamicIQ
K222895 · KPS
GE Medical Systems SCS
Radiology · 60d
Cleared Oct 18, 2022
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
K221321 · DPS
Ge Medical Systems Information...
Cardiovascular · 165d
Cleared Jul 22, 2022
EchoPAC Software Only, EchoPAC Plug-in
K220940 · QIH
GE Medical Systems Ultrasound and...
Radiology · 113d
Cleared Jul 22, 2022
Vivid E80, Vivid E90, Vivid E95
K220882 · IYN
Ge Medical Systems Ultrasound And
Radiology · 119d
Cleared Jul 18, 2022
Vivid iq
K221148 · IYN
GE Medical Systems Ultrasound &...
Radiology · 89d
Cleared Jul 18, 2022
Vivid T8, Vivid T9
K221147 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Jul 15, 2022
Vivid S60N, Vivid S70N
K220619 · IYN
GE Medical Systems Ultrasound and...
Radiology · 134d
Cleared Jun 27, 2022
Venue
K220851 · IYN
GE Medical Systems
Radiology · 96d
Cleared Jun 27, 2022
Venue Fit
K220848 · IYN
GE Medical Systems
Radiology · 96d
Cleared Jun 23, 2022
Mural Perinatal Surveillance
K220732 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 101d
Cleared Jun 21, 2022
Venue Go
K220800 · IYN
GE Medical Systems Ultrasound and...
Radiology · 95d
Cleared Jun 08, 2022
AIR Recon DL
K213717 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 196d
Cleared Jun 06, 2022
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K220358 · IYN
GE Medical Systems Ultrasound and...
Radiology · 118d
Cleared May 11, 2022
Versana Balance
K220446 · IYN
GE Medical Systems Ultrasound and...
Radiology · 84d
Cleared May 02, 2022
Liver Suite
K211180 · JAK
GE Medical Systems SCS
Radiology · 377d