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GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC: FDA-registered device maker in Waukesha, WI, United States, 16 510(k) clearances and 1 PMA approval

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

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC is registered with the FDA (registration 3032008018) in Waukesha, WI, United States. It lists 10 device types. The FDA files 16 510(k) clearances and 1 PMA approval under its listings, the newest dated October 2, 2026. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3032008018
Address: 3200 N Grandview Blvd, Waukesha, WI, United States, 53188
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer, Specification developer
First device listed: February 11, 2013
Registered through: 2027
Brand names listed: 11L-D, 12L-RS, 12S-D, 12S-RS, 3CRF, 3Sc-RS, 4Sc-RS, 6S-D and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Breast Ultrasound	PAA	3	Specification developer	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Manufacturer, Specification developer	accessdata.fda.gov
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	POK	2	Manufacturer	accessdata.fda.gov
Image Acquisition And/Or Optimization Guided By Artificial Intelligence	QJU	2	Manufacturer	accessdata.fda.gov
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan	QVD	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Specification developer	accessdata.fda.gov
Twister, Brace Setting	ITO	1	Specification developer	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
October 2, 2026	K261042	Lung Guidance	QJU	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	accessdata.fda.gov
August 7, 2026	K261668	Venue Go	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary care Diagnostics, LLC	accessdata.fda.gov
March 27, 2026	K254161	Automated Aortic Stenosis Software (AutoAS)	POK	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	accessdata.fda.gov
October 29, 2025	K251985	LOGIQ E10	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
January 15, 2025	K243065	Cardiac Guidance	QJU	Substantially Equivalent	Caption Health, Inc.	accessdata.fda.gov
June 10, 2024	K240206	Venue Sprint	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	K231966	LOGIQ E10	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
February 24, 2023	DEN220063	Caption Interpretation Automated Ejection Fraction Software	QVD	Unknown	Caption Health, Inc.	accessdata.fda.gov
January 19, 2022	K210747	Caption Interpretation Automated Ejection Fraction Software	QIH	Substantially Equivalent	Caption Health	accessdata.fda.gov
February 7, 2020	DEN190040	Caption Guidance	QJU	Unknown	Bay Labs, Inc.	accessdata.fda.gov
May 4, 2018	K180641	Invenia ABUS Viewer	LLZ	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
November 17, 2016	K163077	LOGIQ E9, LOGIQ E9 XDClear 2.0	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 18, 2012	P110006	SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)	PAA	11	February 4, 2025	accessdata.fda.gov

Compare with other makers

Updated October 2, 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.