Data / Medical devices / United States / GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC: FDA-registered device maker in Noblesville, IN, United States, 42 510(k) clearances

Name: GE Medical Systems Ultrasound & Primary Care Diagnostics LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC is registered with the FDA (registration 3002183074) in Noblesville, IN, United States. It lists 4 device types. The FDA files 42 510(k) clearances under its listings, the newest dated January 8, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

FDA registration number: 3002183074
Address: 14470 Bergen Blvd., Noblesville, IN, United States, 46060
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer, Remanufacturer
First device listed: June 30, 2015
Registered through: 2027
Brand names listed: 10T-D, 11L-D, 12L-RS, 12S-D, 12S-RS, 3Sc-RS, 4C-RS, 4V-D and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer, Remanufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer, Remanufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer, Remanufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 8, 2026	K253370	LOGIQ Totus	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
January 7, 2026	K253366	LOGIQ Fortis	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
October 29, 2025	K251985	LOGIQ E10	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
October 29, 2025	K251963	LOGIQ E10s	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
July 25, 2025	K251322	Venue; Venue Go; Venue Fit; Venue Sprint	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
February 11, 2025	K243628	Vivid T9/Vivid T8	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
February 11, 2025	K243620	Vivid iq	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
December 20, 2024	K242168	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
June 10, 2024	K240111	Venue	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
June 10, 2024	K240053	Venue Go	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
June 10, 2024	K234106	Venue Fit	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
November 7, 2023	K231989	LOGIQ E10s, LOGIQ Fortis	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Diagnostic,	accessdata.fda.gov
November 7, 2023	K231966	LOGIQ E10	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
November 3, 2023	K232186	LOGIQ e	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Diagnostic,	accessdata.fda.gov
October 30, 2023	K231965	Voluson Expert 22, Voluson Expert 20, Voluson Expert 18	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
June 20, 2023	K230346	Voluson SWIFT; Voluson SWIFT+	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC	accessdata.fda.gov
July 22, 2022	K220882	Vivid E80, Vivid E90, Vivid E95	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound And	accessdata.fda.gov
July 18, 2022	K221148	Vivid iq	IYN	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	accessdata.fda.gov
July 18, 2022	K221147	Vivid T8, Vivid T9	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
July 15, 2022	K220619	Vivid S60N, Vivid S70N	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
June 27, 2022	K220851	Venue	IYN	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
June 27, 2022	K220848	Venue Fit	IYN	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
June 21, 2022	K220800	Venue Go	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
March 22, 2022	K214039	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
February 17, 2022	K213689	Voluson P6, Voluson P8	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
January 13, 2022	K213642	Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
September 10, 2021	K211488	LOGIQ E10	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
August 27, 2021	K211524	LOGIQ E10s, LOGIQ Fortis	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
June 9, 2021	K211216	Vivid S60N / Vivid S70N	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
January 8, 2021	K203114	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
November 18, 2020	K202233	Venue Go	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
November 13, 2020	K202132	Venue	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
September 9, 2020	K200708	Vivid iq	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound And	accessdata.fda.gov
July 23, 2020	K200743	Vivid E80/ Vivid E90/ Vivid E95	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound And	accessdata.fda.gov
July 1, 2020	K200138	Versana Premier	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound And	accessdata.fda.gov
June 11, 2020	K200998	Versana Active	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
August 29, 2019	K192159	Voluson E6, Voluson E8, Voluson E10	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
December 6, 2018	K181727	Vivid iq	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
November 15, 2018	K181985	Voluson E6, Voluson E8, Voluson E10	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
October 25, 2018	K181685	Vivid E80, Vivid E90, Vivid E95	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
October 19, 2018	K182450	Vivid S60N, Vivid S70N	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
June 18, 2015	K151028	LOGIQ e	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.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.