Medical Device Manufacturer · US , Wauwatosa , WI

GE Medical Systems Ultrasound and Primary Care Diagnostics

63 submissions · 63 cleared · Since 2015
63
Total
63
Cleared
0
Denied

GE Medical Systems Ultrasound and Primary Care Diagnostics — FDA 510(k) Submissions

GE Medical Systems Ultrasound and Primary Care Diagnostics has submitted 63 FDA 510(k) premarket notifications since 2015, of which 63 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, Automated Radiological Image Processing Software, Transducer, Ultrasonic, Diagnostic . Use the specialty filter in the sidebar to narrow results.

63 devices
1–25 of 63
LOGIQ Totus
K253370 · IYN System, Imaging, Pulsed... · Radiology
Jan 2026 100d
LOGIQ Fortis
K253366 · IYN System, Imaging, Pulsed... · Radiology
Jan 2026 99d
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
K252328 · IYN System, Imaging, Pulsed... · Radiology
Nov 2025 122d
LOGIQ E10s
K251963 · IYN System, Imaging, Pulsed... · Radiology
Oct 2025 125d
LOGIQ E10
K251985 · IYN System, Imaging, Pulsed... · Radiology
Oct 2025 124d
Venue; Venue Go; Venue Fit; Venue Sprint
K251322 · IYN System, Imaging, Pulsed... · Radiology
Jul 2025 87d
EchoPAC Software Only / EchoPAC Plug-in
K251342 · QIH Automated Radiological... · Radiology
Jul 2025 77d
Vivid Pioneer
K251169 · IYN System, Imaging, Pulsed... · Radiology
Jul 2025 86d
Voluson? Performance 16; Voluson? Performance 18
K250543 · IYN System, Imaging, Pulsed... · Radiology
May 2025 94d
Vscan Air
K250087 · IYN System, Imaging, Pulsed... · Radiology
May 2025 107d
Vivid iq
K243620 · IYN System, Imaging, Pulsed... · Radiology
Feb 2025 81d
Vivid T9/Vivid T8
K243628 · IYN System, Imaging, Pulsed... · Radiology
Feb 2025 78d
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
K242168 · IYN System, Imaging, Pulsed... · Radiology
Dec 2024 149d
Versana Premier; Versana Premier Lotus; LOGIQ F
K242005 · IYN System, Imaging, Pulsed... · Radiology
Oct 2024 85d
Venue Fit
K234106 · IYN System, Imaging, Pulsed... · Radiology
Jun 2024 167d
Venue Go
K240053 · IYN System, Imaging, Pulsed... · Radiology
Jun 2024 154d
Venue
K240111 · IYN System, Imaging, Pulsed... · Radiology
Jun 2024 146d
Venue Sprint
K240206 · IYN System, Imaging, Pulsed... · Radiology
Jun 2024 137d
Voluson Signature 20, Voluson Signature 18
K233692 · IYN System, Imaging, Pulsed... · Radiology
Mar 2024 111d
LOGIQ Totus
K232381 · IYN System, Imaging, Pulsed... · Radiology
Dec 2023 121d
LOGIQ E10
K231966 · IYN System, Imaging, Pulsed... · Radiology
Nov 2023 127d
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K231965 · IYN System, Imaging, Pulsed... · Radiology
Oct 2023 119d
Vscan Air
K231301 · IYN System, Imaging, Pulsed... · Radiology
Aug 2023 102d
Versana Essential
K223407 · IYN System, Imaging, Pulsed... · Radiology
Feb 2023 98d
EchoPAC Software Only, EchoPAC Plug-in
K220940 · QIH Automated Radiological... · Radiology
Jul 2022 113d
Filters
All63 Radiology 63