Siemens Medical Solutions USA, Inc.

FDA Device Registration & Listing · Plymouth Meeting, PA, US · Registration 2531814

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2531814
FEI Number
3002626007
Entity Name
Siemens Medical Solutions USA, Inc.
City/State/Country
Plymouth Meeting, PA, US
Establishment Address
5168 Campus Dr., Plymouth Meeting, PA 19462, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
SIEMENS MEDICAL SOLUTIONS USA, INC. (Owner Number: 9002915)
Owner / Operator Contact Address
40 Liberty Boulevard, Malvern, PA 19355, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200644
PMA Number
N/A

All Registered Proprietary Names

ACUSON P500 Diagnostic Ultrasound System ACUSON S Family (S1000/ S2000 / S3000) Diagnostic Ultrasound System ACUSON Redwood Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System ACUSON Freestyle Diagnostic Ultrasound System ACUSON SC2000 Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON NX3 Diagnostic Ultrasound System ACUSON Freestyle Diagnostic Ultrasound System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-11-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-11-03
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2020-11-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-11-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-11-03
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-11-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIEMENS MEDICAL SOLUTIONS USA, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1836549 SIEMENS MEDICAL SOLUTIONS USA, INC. ANN ARBOR, MI, US
3012127758 Siemens Healthcare Limited Oakville Ontario, CA
1034973 SIEMENS MEDICAL SOLUTIONS USA, INC. KNOXVILLE, TN, US
3014745562 Siemens Healthcare s.r.o. Kosice-Barca Kosicky, SK
3002619337 Siemens Healthineers Ltd. SEONGNAM-SI Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201670 Siemens Medical Solutions USA, Inc. YSIO X.pree 2020-10-21
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12
K993974 Siemens Medical Solutions USA, Inc. SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR 2000-02-22
K203340 Siemens Medical Solutions USA, Inc. MULTIX Impact C 2021-01-06
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-04 Siemens Medical Solutions USA, Inc. N/A
SONOLINE Antares Diagnostic Ultrasound System.
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2531814. Last updated year: 2026. Please use registration number 2531814 when referencing this establishment in official correspondence.
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