Company · US

GE Medical Systems Ultrasound and Primary Care Diagnostics

FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.

70510(k) clearances (10 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	62
LLZ	System, Image Processing, Radiological	4
QIH	Automated Radiological Image Processing Software	3
ITX	Transducer, Ultrasonic, Diagnostic	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Oct 2, 2026	K261933	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 GE Medical Systems Ultrasound and Primary care Diagnostics, LLC	IYN
Sep 16, 2026	K261623	EchoPAC Software Only / EchoPAC Plug-in (v211) GE Medical Systems Ultrasound and Primary Care Diagnostics	QIH
Sep 2, 2026	K261313	Vivid Explorer/Vivid Advanced/Vivid Focus GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Aug 7, 2026	K261668	Venue Go GE Medical Systems Ultrasound and Primary care Diagnostics, LLC	IYN
Jul 30, 2026	K261835	LOGIQ Focus GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
May 26, 2026	K260398	LOGIQ e GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Mar 24, 2026	K260673	LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 E GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jan 8, 2026	K253370	LOGIQ Totus GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jan 7, 2026	K253366	LOGIQ Fortis GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Nov 24, 2025	K252328	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Oct 29, 2025	K251985	LOGIQ E10 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Oct 29, 2025	K251963	LOGIQ E10s GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jul 25, 2025	K251322	Venue; Venue Go; Venue Fit; Venue Sprint GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jul 16, 2025	K251342	EchoPAC Software Only / EchoPAC Plug-in GE Medical Systems Ultrasound and Primary Care Diagnostics	QIH
Jul 10, 2025	K251169	Vivid Pioneer GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
May 29, 2025	K250543	Voluson Performance 16; Voluson Performance 18 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
May 1, 2025	K250087	Vscan Air GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Feb 11, 2025	K243628	Vivid T9/Vivid T8 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Feb 11, 2025	K243620	Vivid iq GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Dec 20, 2024	K242168	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Oct 2, 2024	K242005	Versana Premier; Versana Premier Lotus; LOGIQ F GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jun 10, 2024	K240206	Venue Sprint GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jun 10, 2024	K240111	Venue GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jun 10, 2024	K240053	Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jun 10, 2024	K234106	Venue Fit GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Mar 7, 2024	K233692	Voluson Signature 20, Voluson Signature 18 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Dec 7, 2023	K232381	LOGIQ Totus GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Nov 7, 2023	K231966	LOGIQ E10 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Oct 30, 2023	K231965	Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Aug 15, 2023	K231301	Vscan Air GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Feb 15, 2023	K223407	Versana Essential GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jul 22, 2022	K220940	EchoPAC Software Only, EchoPAC Plug-in GE Medical Systems Ultrasound and Primary Care Diagnostics	QIH
Jul 18, 2022	K221147	Vivid T8, Vivid T9 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jul 15, 2022	K220619	Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jun 21, 2022	K220800	Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jun 6, 2022	K220358	Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
May 11, 2022	K220446	Versana Balance GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Mar 22, 2022	K214039	LOGIQ P10, LOGIQ P9, LOGIQ P8 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Sep 10, 2021	K210438	Versana Premier GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jun 9, 2021	K211216	Vivid S60N / Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Mar 5, 2021	K202658	Vivid E80/ Vivid E90/ Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jan 8, 2021	K203114	LOGIQ P10, LOGIQ P9, LOGIQ P8 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Dec 29, 2020	K203137	Venue Fit GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Nov 20, 2020	K202035	Vscan Air GE Medical Systems Ultrasound and Primary Care Diagnostics	ITX
Nov 18, 2020	K202233	Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Nov 13, 2020	K202132	Venue GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Oct 11, 2020	K201828	Voluson SWIFT, Voluson SWIFT+ GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Sep 18, 2020	K200852	EchoPAC Software Only, EchoPAC Plug-In GE Medical Systems Ultrasound and Primary Care Diagnostics	LLZ
Sep 9, 2020	K200851	Vivid T8, Vivid T9 GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN
Jul 16, 2020	K200497	Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics	IYN

Newest 50 of 70.

Latest recalls

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