GE Medical Systems Ultrasound and Primary Care Diagnostics FDA Approvals

0 new drug approvals and 40 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
EchoPAC Software Only / EchoPAC Plug-in (v211)510(k)Sep 16, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 16, 2026
Vivid Explorer/Vivid Advanced/Vivid Focus510(k)Sep 2, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 2, 2026
LOGIQ Focus510(k)Jul 30, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 30, 2026
LOGIQ e510(k)May 26, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 26, 2026
LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power510(k)Mar 24, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 24, 2026
LOGIQ Totus510(k)Jan 8, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 8, 2026
LOGIQ Fortis510(k)Jan 7, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 7, 2026
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22510(k)Nov 24, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 24, 2025
LOGIQ E10s510(k)Oct 29, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 29, 2025
LOGIQ E10510(k)Oct 29, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 29, 2025
Venue; Venue Go; Venue Fit; Venue Sprint510(k)Jul 25, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 25, 2025
EchoPAC Software Only / EchoPAC Plug-in510(k)Jul 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 16, 2025
Vivid Pioneer510(k)Jul 10, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 10, 2025
Voluson Performance 16; Voluson Performance 18510(k)May 29, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 29, 2025
Vscan Air510(k)May 1, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 1, 2025
Vivid T9/Vivid T8510(k)Feb 11, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 11, 2025
Vivid iq510(k)Feb 11, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 11, 2025
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22510(k)Dec 20, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 20, 2024
Versana Premier; Versana Premier Lotus; LOGIQ F510(k)Oct 2, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 2, 2024
Venue510(k)Jun 10, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2024
Venue Go510(k)Jun 10, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2024
Venue Fit510(k)Jun 10, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2024
Venue Sprint510(k)Jun 10, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2024
Voluson Signature 20, Voluson Signature 18510(k)Mar 7, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 7, 2024
LOGIQ Totus510(k)Dec 7, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 7, 2023
LOGIQ E10510(k)Nov 7, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 7, 2023
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18510(k)Oct 30, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 30, 2023
Vscan Air510(k)Aug 15, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 15, 2023
Versana Essential510(k)Feb 15, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 15, 2023
EchoPAC Software Only, EchoPAC Plug-in510(k)Jul 22, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 22, 2022
Vivid T8, Vivid T9510(k)Jul 18, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 18, 2022
Vivid S60N, Vivid S70N510(k)Jul 15, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 15, 2022
Venue Go510(k)Jun 21, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 21, 2022
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18510(k)Jun 6, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 6, 2022
Versana Balance510(k)May 11, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 11, 2022
LOGIQ P10, LOGIQ P9, LOGIQ P8510(k)Mar 22, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 22, 2022
Versana Premier510(k)Sep 10, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 10, 2021
Vivid S60N / Vivid S70N510(k)Jun 9, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 9, 2021
Vivid E80/ Vivid E90/ Vivid E95510(k)Mar 5, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 5, 2021
LOGIQ P10, LOGIQ P9, LOGIQ P8510(k)Jan 8, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 8, 2021

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