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Siemens Medical Solutions USA, Inc.: FDA-registered device maker in Plymouth Meeting, PA, United States, 4 510(k) clearances

Name: Siemens Medical Solutions USA, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Siemens Medical Solutions USA, Inc. is registered with the FDA (registration 2531814) in Plymouth Meeting, PA, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 15, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 2531814
FEI number: 3002626007
Address: 5168 Campus Dr., Plymouth Meeting, PA, United States, 19462
Owner or operator: SIEMENS MEDICAL SOLUTIONS USA, INC. (9002915)
Roles: Manufacturer, Specification developer
First device listed: November 20, 2012
Registered through: 2026
Brand names listed: ACUSON Freestyle Diagnostic Ultrasound System, ACUSON NX3 Diagnostic Ultrasound System, ACUSON NX3 Elite Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON Redwood Diagnostic Ultrasound System, ACUSON S Family (S1000/ S2000 / S3000) Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Sequoia Diagnostic Ultrasound System and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle Guide Kit	OIJ	2	Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer, 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
October 15, 2020	K202683	ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
April 10, 2020	K200644	ACUSON Freestyle Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
September 28, 2016	K162417	Acuson Freestyle Ultrasound System	IYN	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.	accessdata.fda.gov
November 19, 2010	K100598	PENRITH ELETTRA ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Penrith Corporation	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
February 2, 2004	28393	Not yet classified	Terminated	Acuson Cypress Echocardiography System	software problem - mode does not appear on screen	accessdata.fda.gov
April 1, 2003	26456	Not yet classified	Terminated	Acuson Cypress Echocardiography System. Imaging System	software problem - loss of data	accessdata.fda.gov

Compare with other makers

Updated October 15, 2020. 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.