Medical Device Manufacturer · US , Waukesha , WI

Ge Medical Systems, LLC

102 submissions · 102 cleared · Since 2003
102
Total
102
Cleared
0
Denied

Ge Medical Systems, LLC — FDA 510(k) Submissions

Ge Medical Systems, LLC has submitted 102 FDA 510(k) premarket notifications since 2003, of which 102 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Nuclear Magnetic Resonance Imaging, System, X-ray, Tomography, Computed, System, Tomography, Computed, Emission, System, X-ray, Mobile, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.

102 devices
1–25 of 102
SIGNA? Bolt
K253780 · LNH System, Nuclear Magnetic... · Radiology
Feb 2026 72d
SIGNA? Sprint Select
K253779 · LNH System, Nuclear Magnetic... · Radiology
Feb 2026 71d
AIR Recon DL
K252379 · LNH System, Nuclear Magnetic... · Radiology
Dec 2025 146d
SIGNA? Sprint
K251399 · LNH System, Nuclear Magnetic... · Radiology
Sep 2025 128d
Revolution Vibe
K250941 · JAK System, X-ray,... · Radiology
Aug 2025 126d
Sonic DL
K243667 · LNH System, Nuclear Magnetic... · Radiology
Jun 2025 190d
SIGNA Prime Elite
K250379 · LNH System, Nuclear Magnetic... · Radiology
Mar 2025 34d
SIGNA MAGNUS
K241242 · LNH System, Nuclear Magnetic... · Radiology
Oct 2024 167d
ECG-less Cardiac
K233750 · JAK System, X-ray,... · Radiology
Apr 2024 132d
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
K223491 · QBS Radiological Computer... · Radiology
May 2023 185d
Auto Segmentation
K230082 · QKB Radiological Image... · Radiology
May 2023 113d
Spectral Bone Marrow
K223514 · JAK System, X-ray,... · Radiology
Mar 2023 107d
Deep Learning Image Reconstruction
K213999 · JAK System, X-ray,... · Radiology
Feb 2022 59d
SIGNA PET/MR
K213709 · OUO Tomographic Imager... · Radiology
Jan 2022 57d
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition
K213715 · JAK System, X-ray,... · Radiology
Dec 2021 23d
Critical Care Suite with Endotracheal Tube Positing AI algorithm
K211161 · QIH Automated Radiological... · Radiology
Oct 2021 193d
Discovery MI Gen2
K211846 · KPS System, Tomography,... · Radiology
Aug 2021 66d
SIGNA 7.0T
K211118 · LNH System, Nuclear Magnetic... · Radiology
May 2021 28d
AMX Navigate
K210982 · IZL System, X-ray, Mobile · Radiology
Apr 2021 27d
MaxFOV 2
K203617 · JAK System, X-ray,... · Radiology
Mar 2021 81d
Deep Learning Image Reconstruction for Gemstone Spectral Imaging
K201745 · JAK System, X-ray,... · Radiology
Dec 2020 167d
SIGNA 7.0T
K201615 · LNH System, Nuclear Magnetic... · Radiology
Oct 2020 122d
Critical Care Suite
K183182 · QFM Radiological... · Radiology
Aug 2019 266d
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
K191777 · JAK System, X-ray,... · Radiology
Jul 2019 24d
Deep Learning Image Reconstruction
K183202 · JAK System, X-ray,... · Radiology
Apr 2019 144d

Looking for a specific device from Ge Medical Systems, LLC? Search by device name or K-number.

Search all Ge Medical Systems, LLC devices
Filters
All102 Radiology 102