SIEMENS MEDICAL SOLUTIONS USA, INC.

FDA Device Registration & Listing · ISSAQUAH, WA, US · Registration 3023245

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
3023245
FEI Number
3023245
Entity Name
SIEMENS MEDICAL SOLUTIONS USA, INC.
City/State/Country
ISSAQUAH, WA, US
Establishment Address
22010 S.E. 51ST ST., ISSAQUAH, WA 98029, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,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
Y
Expiration Date (Year)
2026
510(k) Number
K192085
PMA Number
N/A

All Registered Proprietary Names

ACUSON Sequoia Diagnostic Ultrasound System ACUSON Juniper Select Diagnostic Ultrasound System ACUSON Juniper Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System ACUSON NX3 Diagnostic Ultrasound System Acuson Freestyle Diagnostic Ultrasound System ACUSON AcuNav Volume ICE Catheter AcuNav 10F Diagnostic Ultrasound Catheter AcuNav 8F Diagnostic Ultrasound Catheter ACUSON SC2000 Diagnostic Ultrasound System ACUSON SC2000 Diagnostic Ultrasound System ACUSON SC2000 Diagnostic Ultrasound System ACUSON P500 Diagnostic Ultrasound System ACUSON Sequoia Select Diagnostic Ultrasound System ACUSON Origin Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Origin ICE Diagnostic Ultrasound System ACUSON P500 Ultrasound System ACUSON P500 ICE Ultrasound System ACUSON Redwood Diagnostic Ultrasound System ACUSON P200 Diagnostic Ultrasound System ACUSON Juniper Diagnostic Ultrasound System ACUSON Freestyle Diagnostic Ultrasound System ACUSON Maple Diagnostic Ultrasound System ACUSON Maple Select Diagnostic Ultrasound System ACUSON Origin ICE Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Origin Diagnostic Ultrasound System ACUSON Sequoia Select Diagnostic Ultrasound System eSie Apps Suite syngo Ultrasound Apps Suite ACUSON Antares Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON S2000 ABVS Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Juniper Diagnostic Ultrasound System ACUSON Juniper Select Diagnostic Ultrasound System AcuNav Lumos 4D ICE Catheter AcuNav Volume ICE Catheter ACUSON P500 Diagnostic Ultrasound System ACUSON Origin Diagnostic Ultrasound System ACUSON Sequoia Select Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System AcuNav Crystal Ultrasound Catheter AcuNav Crystal G Ultrasound Catheter Acuson S2000 Diagnostic Ultrasound System Acuson S1000 Diagnostic Ultrasound System Acuson S3000 Diagnostic Ultrasound System ACUSON Maple Diagnostic Ultrasound System ACUSON Maple Select Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Sequoia Select Diagnostic Ultrasound System ACUSON Origin ICE Diagnostic Ultrasound System ACUSON Origin Diagnostic Ultrasound System ACUSON Redwood Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Juniper Diagnostic Ultrasound System ACUSON Juniper Select Diagnostic Ultrasound System ACUSON SC2000 Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Sequoia Select Diagnostic Ultrasound System syngo Ultrasound Breast Analysis (sUSBA)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-02-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-02-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-02-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-08-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-08-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-08-22
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2022-08-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-10-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-10-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-10-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-04-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-04-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-04-10
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2018-01-08
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2017-09-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-13
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-06-13
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-06-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-30
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-04-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-11-15
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-11-15
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2021-11-15
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-11-15
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-11-15
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-02-17
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2022-02-17
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2022-02-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-02-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-02-17
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-06-17
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2026-06-17
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2026-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-06-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-06-17
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-06-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-06-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-06-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-06-13
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2024-06-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-08-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-08-19
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-08-19
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-02-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-02-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-02-01
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
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-11-21
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2025-11-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-11-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-11-21
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-11-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-11-20
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2024-11-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-11-20
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2024-11-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-11-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2015-03-05
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2013-01-23
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-01-23
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-01-23
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-07-30
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2020-07-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-07-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-07-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-01-23
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-01-23
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2013-01-23
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-16
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-16
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2020-04-16
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-16
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2023-03-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-03-01
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-03-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-03-01
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2021-10-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-04-10
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2017-04-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2017-04-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-04-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-11-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-11-03
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2023-11-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-11-03
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2023-11-03
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2023-11-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-11-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-11-04
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2014-11-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-11-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-09-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-09-28
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-09-28
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2023-09-28
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-08-29
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2025-08-29
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-08-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-08-29
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2025-08-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-08-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-05-26
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-05-26
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2021-05-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-05-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-07-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-07-20
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2021-07-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-07-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-11-20
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2025-11-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-11-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-11-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-05-31
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2018-05-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-05-31
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-05-31
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2023-02-08
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2023-02-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2023-02-08
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2023-02-08
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2019-08-08

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
2531814 Siemens Medical Solutions USA, Inc. Plymouth Meeting, PA, US
1034973 SIEMENS MEDICAL SOLUTIONS USA, INC. KNOXVILLE, TN, US
3014745562 Siemens Healthcare s.r.o. Kosice-Barca Kosicky, SK

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06
K930964 Acuson Corp. ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) 1994-10-26
K052355 U-Systems, Inc. AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS 2005-09-14

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-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023245. Last updated year: 2026. Please use registration number 3023245 when referencing this establishment in official correspondence.
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