Medical Device Manufacturer · US , Waukesha , WI

Ge Healthcare

168 submissions · 168 cleared · Since 2004
168
Total
168
Cleared
0
Denied

Ge Healthcare — FDA 510(k) Submissions

Ge Healthcare has submitted 168 FDA 510(k) premarket notifications since 2004, of which 168 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Imaging, Pulsed Doppler, Ultrasonic, System, Image Processing, Radiological, System, Tomography, Computed, Emission, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), Full Field Digital, System, X-ray, Mammographic . Use the specialty filter in the sidebar to narrow results.

168 devices
1–25 of 168
View
K253639 · LLZ System, Image Processing,... · Radiology
Jan 2026 50d
MR Contour DL
K242925 · QKB Radiological Image... · Radiology
Apr 2025 189d
Digital Expert Access with Remote Scanning
K232346 · LNH System, Nuclear Magnetic... · Radiology
Oct 2023 84d
Precision DL
K223212 · KPS System, Tomography,... · Radiology
Apr 2023 192d
Xeleris V Processing and Review System
K221680 · LLZ System, Image Processing,... · Radiology
Mar 2023 265d
Omni Legend
K221932 · KPS System, Tomography,... · Radiology
Sep 2022 63d
Voluson P6, Voluson P8
K213689 · IYN System, Imaging, Pulsed... · Radiology
Feb 2022 86d
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
K213642 · IYN System, Imaging, Pulsed... · Radiology
Jan 2022 56d
LOGIQ E10
K211488 · IYN System, Imaging, Pulsed... · Radiology
Sep 2021 120d
LOGIQ E10s, LOGIQ Fortis
K211524 · IYN System, Imaging, Pulsed... · Radiology
Aug 2021 102d
MyoSPECT, MyoSpect ES
K212004 · KPS System, Tomography,... · Radiology
Aug 2021 60d
Senographe Pristina
K211725 · MUE Full Field Digital,... · Radiology
Aug 2021 63d
SenoBright HD
K211215 · MUE Full Field Digital,... · Radiology
Jun 2021 60d
Universal Viewer
K211312 · LLZ System, Image Processing,... · Radiology
May 2021 21d
StarGuide
K210173 · KPS System, Tomography,... · Radiology
Mar 2021 66d
Panda iRes Warmer, Giraffe Warmer
K201628 · FMT Warmer, Infant Radiant · General Hospital
Feb 2021 241d
Voluson E10
K201768 · IYN System, Imaging, Pulsed... · Radiology
Oct 2020 115d
Xeleris V Processing and Review Systems
K201103 · LLZ System, Image Processing,... · Radiology
Sep 2020 154d
Pristina Serena Bright
K193334 · MUE Full Field Digital,... · Radiology
May 2020 165d
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
K200494 · MHX Monitor, Physiological,... · Cardiovascular
Mar 2020 30d
Carescape One
K190008 · MHX Monitor, Physiological,... · Cardiovascular
Dec 2019 352d
Voluson E6, Voluson E8, Voluson E10
K192159 · IYN System, Imaging, Pulsed... · Radiology
Aug 2019 20d
Sample Imaging for Senographe Pristina
K190809 · MUE Full Field Digital,... · Radiology
Jul 2019 122d
Pristina Serena 3D
K182951 · MUE Full Field Digital,... · Radiology
Jan 2019 87d
Centricity Universal Viewer
K182419 · LLZ System, Image Processing,... · Radiology
Dec 2018 100d

Looking for a specific device from Ge Healthcare? Search by device name or K-number.

Search all Ge Healthcare devices
Filters