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Data / Medical devices / South Korea / Ge Ultrasound Korea, Ltd.

Ge Ultrasound Korea, Ltd.: FDA-registered device maker in Seongnam-Si Gyeonggi, South Korea, 28 510(k) clearances

Ge Ultrasound Korea, Ltd. is registered with the FDA (registration 9710090) in Seongnam-Si Gyeonggi, South Korea. It lists 4 device types. The FDA files 28 510(k) clearances under its listings, the newest dated January 8, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Ge Ultrasound Korea, Ltd.
FDA registration number
9710090
FEI number
3003208270
Address
9, Sunhwan-ro 214beon-gil, Jungwon-gu, Gyeonggi-do, Seongnam-Si Gyeonggi, South Korea, 13204
Owner or operator
GE HealthCare Technologies Inc. (9912004)
Roles
Manufacturer
First device listed
October 7, 2015
Registered through
2027
Brand names listed
11L-D, 12L-RS, 12S-D, 12S-RS, 3Sc-RS, 4C-RS, 6S-D, 6S-RS and more

Devices it lists

DeviceProduct codeClassRoleSource
Automated Radiological Image Processing SoftwareQIH2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 8, 2026K253370LOGIQ TotusIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
January 7, 2026K253366LOGIQ FortisIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
October 29, 2025K251985LOGIQ E10IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
October 29, 2025K251963LOGIQ E10sIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
May 29, 2025K250543Voluson™ Performance 16; Voluson™ Performance 18IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
March 7, 2024K233692Voluson Signature 20, Voluson Signature 18IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
December 7, 2023K232381LOGIQ TotusIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
November 7, 2023K231989LOGIQ E10s, LOGIQ FortisIYNSubstantially EquivalentGe Medical Systems Ultrasound and Primary Care Diagnostic,accessdata.fda.gov
November 7, 2023K231966LOGIQ E10IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
June 20, 2023K230346Voluson SWIFT; Voluson SWIFT+IYNSubstantially EquivalentGe Medical Systems Ultrasound & Primary Care Diagnostic, LLCaccessdata.fda.gov
March 22, 2022K214039LOGIQ P10, LOGIQ P9, LOGIQ P8IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
February 17, 2022K213689Voluson P6, Voluson P8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
January 13, 2022K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
September 10, 2021K211488LOGIQ E10IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
August 27, 2021K211524LOGIQ E10s, LOGIQ FortisIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
January 8, 2021K203114LOGIQ P10, LOGIQ P9, LOGIQ P8IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
October 11, 2020K201828Voluson SWIFT, Voluson SWIFT+IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
April 1, 2020K200119LOGIQ E10sIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
September 20, 2018K181783LOGIQ P9; LOGIQ P7IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
March 29, 2018K180535Voluson P6 and Voluson P8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
March 13, 2018K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
April 11, 2017K170445LOGIQ S8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
February 10, 2017K163596LOGIQ P9 and LOGIQ P7IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
May 5, 2016K161047LOGIQ P9 and LOGIQ P7IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
April 26, 2016K160162Voluson P6, Voluson P8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
February 26, 2016K160182LOGIQ S7 ExpertIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
February 25, 2016K160184Voluson S6, Voluson S8, Voluson S10IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
September 29, 2015K152195LOGIQ S8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov

Compare with other makers

Updated January 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.