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Sound Technology Inc.: FDA-registered device maker in State College, PA, United States, 28 510(k) clearances

Name: Sound Technology Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sound Technology Inc. is registered with the FDA (registration 2532090) in State College, PA, United States. It lists 5 device types. The FDA files 28 510(k) clearances under its listings, the newest dated September 2, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Sound Technology Inc.

FDA registration number: 2532090
FEI number: 3003408255
Address: 401 Science Park Road, State College, PA, United States, 16803
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer
First device listed: August 5, 2014
Registered through: 2027
Brand names listed: 10-D, 10T-D, 11L-D, 1202 (Flex Focus), 12L-RS, 12S-D, 12S-RS, 1300 (bkSpecto) and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	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
September 2, 2026	K261313	Vivid Explorer/Vivid Advanced/Vivid Focus	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
July 10, 2025	K251169	Vivid Pioneer	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
October 23, 2023	K231764	Ultrasound System 1300	IYN	Substantially Equivalent	Bk Medical Aps	accessdata.fda.gov
April 11, 2023	K223830	Ultrasound System 2300	IYN	Substantially Equivalent	Bk Medical Aps	accessdata.fda.gov
February 16, 2023	K223832	Vivid S60N, Vivid S70N	IYN	Substantially Equivalent	Ge Medical System Ultrasound and Primary Care Diagnostics	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 15, 2022	K220619	Vivid S60N, Vivid S70N	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	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
March 5, 2021	K202658	Vivid E80/ Vivid E90/ Vivid E95	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 16, 2020	K200497	Vivid S60N, Vivid S70N	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
December 6, 2018	K181727	Vivid iq	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	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
August 1, 2018	K180737	Ultrasound Scanner System bk2300	IYN	Substantially Equivalent	Bk Medical Aps	accessdata.fda.gov
February 23, 2018	K173569	Ultrasound System 1300	IYN	Substantially Equivalent	Bk Medical Aps	accessdata.fda.gov
November 2, 2017	K173341	Vivid E80, Vivid E90, Vivid E95	IYN	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
June 14, 2017	K170878	Vivid S60N, Vivid S70N	IYN	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	accessdata.fda.gov
June 12, 2017	K170823	Vivid E80, Vivid E90, Vivid E95	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	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
August 5, 2016	K161706	Vivid iq	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Diagnostics L	accessdata.fda.gov
March 4, 2015	K150087	Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System	IYN	Substantially Equivalent	Ge Vingmed Ultrasound AS	accessdata.fda.gov
October 10, 2014	K142323	Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Ge Medical Systems Israel , Ltd.	accessdata.fda.gov
May 15, 2014	K141093	6VT-D ULTRASOUND TRANSDUCER	ITX	Substantially Equivalent	Ge Vingmed Ultrasound AS	accessdata.fda.gov
January 10, 2014	K132335	ULTRASOUND SCANNER FLEX FOCUS 1202	IYN	Substantially Equivalent	B-K Medical Aps	accessdata.fda.gov

Compare with other makers

Updated September 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.