Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

287 results for "Ge Healthcare"
1–24 of 287
Search insights Median review: 66d Cleared: 100% Top manufacturer: Ge Healthcare Lead specialty: Radiology
Cleared Sep 01, 2026
Carescape ONE
K260656 · MHX
GE Healthcare Finland Oy
Cardiovascular · 186d
Cleared Aug 28, 2026
Carescape Canvas 1000
K260343 · MHX
GE Healthcare Finland Oy
Cardiovascular · 207d
Cleared Mar 23, 2026
True Definition DL
K253686 · JAK
Ge Healthcare Japan Corporation
Radiology · 122d
Cleared Jan 23, 2026
3.0T AIR 32CH HNA
K253738 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 60d
Cleared Jan 08, 2026
View
K253639 · LLZ
Ge Healthcare
Radiology · 50d
Cleared Apr 14, 2025
Merge Universal Viewer (MUV)
K250301 · LLZ
Merge Healthcare Incorporated
Radiology · 73d
Cleared Apr 01, 2025
MR Contour DL
K242925 · QKB
Ge Healthcare
Radiology · 189d
Cleared Jan 03, 2025
Clarify DL
K241350 · LLZ
Ge Medical Systems Israel, Functional...
Radiology · 235d
Cleared Dec 27, 2024
OEC One ASD
K240828 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 276d
Cleared Nov 12, 2024
Change Healthcare Stratus Imaging PACS
K241981 · LLZ
Change Healthcare Canada Company
Radiology · 130d
Cleared Jul 02, 2024
ViewPoint 6
K241300 · LLZ
Ge Healthcare GmbH
Radiology · 54d
Cleared Jun 21, 2024
Merge Hemo, Model RCSV2
K233326 · DQK
Merge Healthcare Incorporated
Cardiovascular · 266d
Cleared Apr 11, 2024
True Enhance DL
K233698 · JAK
Ge Healthcare Japan Corporation
Radiology · 146d
Cleared Jan 19, 2024
SIGNA Champion
K233728 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 59d
Cleared Oct 27, 2023
Digital Expert Access with Remote Scanning
K232346 · LNH
Ge Healthcare
Radiology · 84d
Cleared Sep 11, 2023
Change Healthcare Cardiology Hemodynamics™
K230881 · MWI
Change Healthcare Israel , Ltd.
Cardiovascular · 165d
Cleared May 30, 2023
Sonic DL
K223523 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 188d
Cleared Apr 27, 2023
Precision DL
K223212 · KPS
Ge Healthcare
Radiology · 192d
Cleared Apr 20, 2023
Deep Learning Image Reconstruction
K230807 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Apr 06, 2023
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19,...
K223531 · MHX
GE Healthcare Finland Oy
Cardiovascular · 134d
Cleared Mar 14, 2023
ONE-CUF
K230145 · DXQ
Ge Medical Systems Information...
Cardiovascular · 55d
Cleared Mar 01, 2023
Xeleris V Processing and Review System
K221680 · LLZ
Ge Healthcare
Radiology · 265d
Cleared Feb 13, 2023
SIGNA Victor
K223439 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 91d
Cleared Jan 03, 2023
3.0T 16ch AIR AA
K223378 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 57d