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"
1–24 of 719
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared Oct 02, 2026
Voluson Expert 18
K261933 · IYN
GE Medical Systems Ultrasound and...
Radiology · 115d
Cleared Oct 02, 2026
Lung Guidance
K261042 · QJU
GE Medical Systems Ultrasound &...
Radiology · 185d
Cleared Sep 16, 2026
EchoPAC Software Only / EchoPAC Plug-in (v211)
K261623 · QIH
GE Medical Systems Ultrasound and...
Radiology · 124d
Cleared Sep 02, 2026
Vivid Explorer/Vivid Advanced/Vivid Focus
K261313 · IYN
GE Medical Systems Ultrasound and...
Radiology · 134d
Cleared Aug 13, 2026
AIR Recon DL
K253808 · LNH
GE Medical Systems
Radiology · 258d
Cleared Aug 07, 2026
Venue Go
K261668 · IYN
GE Medical Systems Ultrasound and...
Radiology · 79d
Cleared Jul 30, 2026
LOGIQ Focus
K261835 · IYN
GE Medical Systems Ultrasound and...
Radiology · 58d
Cleared Jul 21, 2026
CardIQ Suite
K253770 · JAK
GE Medical Systems SCS
Radiology · 237d
Cleared Jun 24, 2026
Enhanced Boundary for PCCT
K253560 · JAK
Ge Medical Systems, LLC
Radiology · 219d
Cleared May 26, 2026
LOGIQ e
K260398 · IYN
GE Medical Systems Ultrasound and...
Radiology · 109d
Cleared Apr 20, 2026
Lunar Astra
K252718 · KGI
GE Medical Systems Ultrasound &...
Radiology · 235d
Cleared Apr 14, 2026
Critical Care Suite with Enteric Tube Positioning AI Algorithm
K253502 · QIH
Ge Medical Systems, LLC
Radiology · 166d
Cleared Mar 27, 2026
Automated Aortic Stenosis Software (AutoAS)
K254161 · POK
GE Medical Systems Ultrasound &...
Radiology · 95d
Cleared Mar 24, 2026
LOGIQ Vita
K260673 · IYN
GE Medical Systems Ultrasound and...
Radiology · 22d
Cleared Mar 24, 2026
Senographe Pristina
K260087 · MUE
GE Medical Systems SCS
Radiology · 71d
Cleared Mar 20, 2026
Photonova Spectra, Photonova Spectra Select
K253520 · JAK
Ge Medical Systems, LLC
Radiology · 128d
Cleared Feb 06, 2026
SIGNA™ Bolt
K253780 · LNH
Ge Medical Systems, LLC
Radiology · 72d
Cleared Feb 05, 2026
SIGNA™ Sprint Select
K253779 · LNH
Ge Medical Systems, LLC
Radiology · 71d
Cleared Jan 26, 2026
MAC 7 Resting ECG Analysis System
K251670 · DPS
Ge Medical Systems Information...
Cardiovascular · 241d
Cleared Jan 08, 2026
LOGIQ Totus
K253370 · IYN
GE Medical Systems Ultrasound and...
Radiology · 100d
Cleared Jan 07, 2026
LOGIQ Fortis
K253366 · IYN
GE Medical Systems Ultrasound and...
Radiology · 99d
Cleared Dec 23, 2025
AIR Recon DL
K252379 · LNH
Ge Medical Systems, LLC
Radiology · 146d
Cleared Dec 09, 2025
Allia Moveo
K251199 · OWB
GE Medical Systems SCS
Radiology · 235d
Cleared Nov 24, 2025
Voluson Expert 18
K252328 · IYN
GE Medical Systems Ultrasound and...
Radiology · 122d