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GE Medical Systems Ultrasound and Primary Care Diagnostics LLC: FDA-registered device maker in Wauwatosa, WI, United States, 12 510(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 3005860720) in Wauwatosa, WI, United States. It lists 5 device types. The FDA files 12 510(k) clearances and 1 PMA approval under its listings, the newest dated November 7, 2023. 11 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3005860720
Address: 9900 Innovation Drive, Wauwatosa, WI, United States, 53226
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer, Specification developer
First device listed: February 11, 2013
Registered through: 2027
Brand names listed: 12L-RS, 12S-RS, 3Sc-RS, 6S-D, 6S-RS, 6Tc-RS, 8C-RS, 9L-RS and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Breast Ultrasound	PAA	3	Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer, 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
November 7, 2023	K231966	LOGIQ E10	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
September 10, 2021	K211488	LOGIQ E10	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
December 29, 2020	K203137	Venue Fit	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
January 28, 2019	K183362	Venue GO	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
May 4, 2018	K180641	Invenia ABUS Viewer	LLZ	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
May 2, 2018	K180599	Venue	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
June 21, 2017	K170714	Venue	IYN	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 2, 2018	80165	Class II	Terminated	T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adju	A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction. If these parts were installed from customer owned stock on the T2100 Treadmill, uncontrolled walking belt motion during a stress exercise test could occur.	accessdata.fda.gov
March 22, 2018	80928	Class II	Terminated	GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adu	The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.	accessdata.fda.gov
October 1, 2009	54178	Not yet classified	Terminated	Discovery CT 750 HD model numbers: 5232083, 5232083-2, 5232083-3, and 5232083-4. For head, whole body, cardiac and vascular X-ray Computed Tomography applications.	Failure to properly document the CTDI in the Technical Reference or User Manual.	accessdata.fda.gov
March 10, 2009	52002	Not yet classified	Terminated	GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" clinical Information Center central station is intended to collect information from a network and disp	GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety.	accessdata.fda.gov
February 27, 2009	51253	Not yet classified	Terminated	GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6,5.0.7, 5.0.8 and 4.1. The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner.	GE Healthcare is aware of potential network time issues associated with the time change aspects of certain CARESCAPE CIC Pro" software versions. These issues may impact patient safety. No reported patient injuries or illnesses for the use of this device in conjunction with this device correction.	accessdata.fda.gov
February 1, 2009	53692	Not yet classified	Terminated	iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD	Failure to properly pre-indicate the technique factors to be used during a patient scan.	accessdata.fda.gov
October 9, 2008	53260	Not yet classified	Terminated	GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector).	GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE Healthcare found the AKR calibration procedure does not exactly reflect the worst-case clinical usage of the product. Thi	accessdata.fda.gov
July 6, 2007	39400	Not yet classified	Terminated	GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.	When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.	accessdata.fda.gov
August 4, 2006	36034	Not yet classified	Terminated	GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The receivers; -The receiver	When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC (Clinical Information Center) does not occur.	accessdata.fda.gov
June 23, 2006	35826	Not yet classified	Terminated	ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with ant	System Warning Alarm failure: When a patient being monitored is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC does not occur.	accessdata.fda.gov
February 6, 2006	51278	Not yet classified	Terminated	Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastroin	GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as ---(3 dashes) when the monitor was used continuously for 49 days without a cold start. A missed alarm or missed HR value could cause a delay in recognition	accessdata.fda.gov

Compare with other makers

Updated February 4, 2025. 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.