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

119 results for "Ge Medical Systems, LLC"
1–24 of 119
Search insights Median review: 81d Cleared: 100% Top manufacturer: Ge Medical Systems, LLC Lead specialty: Radiology
Cleared Jun 24, 2026
Enhanced Boundary for PCCT
K253560 · JAK
Ge Medical Systems, LLC
Radiology · 219d
Cleared Apr 14, 2026
Critical Care Suite with Enteric Tube Positioning AI Algorithm
K253502 · QIH
Ge Medical Systems, LLC
Radiology · 166d
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 Dec 23, 2025
AIR Recon DL
K252379 · LNH
Ge Medical Systems, LLC
Radiology · 146d
Cleared Sep 11, 2025
SIGNA™ Sprint
K251399 · LNH
Ge Medical Systems, LLC
Radiology · 128d
Cleared Aug 01, 2025
Revolution Vibe
K250941 · JAK
Ge Medical Systems, LLC
Radiology · 126d
Cleared Jun 05, 2025
Sonic DL
K243667 · LNH
Ge Medical Systems, LLC
Radiology · 190d
Cleared Mar 17, 2025
SIGNA Prime Elite
K250379 · LNH
Ge Medical Systems, LLC
Radiology · 34d
Cleared Oct 17, 2024
SIGNA MAGNUS
K241242 · LNH
Ge Medical Systems, LLC
Radiology · 167d
Cleared Apr 02, 2024
ECG-less Cardiac
K233750 · JAK
Ge Medical Systems, LLC
Radiology · 132d
Cleared Jan 19, 2024
SIGNA Champion
K233728 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 59d
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 09, 2023
Spectral Bone Marrow
K223514 · JAK
Ge Medical Systems, LLC
Radiology · 107d
Cleared Feb 18, 2022
Deep Learning Image Reconstruction
K213999 · JAK
Ge Medical Systems, LLC
Radiology · 59d
Cleared Feb 11, 2022
SIGNA Artist Evo
K213603 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 88d
Cleared Jan 20, 2022
SIGNA PET/MR
K213709 · OUO
Ge Medical Systems, LLC
Radiology · 57d
Cleared Jan 20, 2022
SIGNA Hero
K213668 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 59d
Cleared Jan 16, 2022
SIGNA Prime
K211980 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 205d
Cleared Dec 17, 2021
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex...
K213715 · JAK
Ge Medical Systems, LLC
Radiology · 23d
Cleared Oct 29, 2021
Critical Care Suite with Endotracheal Tube Positing AI algorithm
K211161 · QIH
Ge Medical Systems, LLC
Radiology · 193d
Cleared Sep 17, 2021
Deep Learning Image Reconstruction
K212067 · JAK
Ge Healthcare Japan Corporation
Radiology · 77d