Data / Medical devices / United States / Siemens Medical Solutions Usa, Inc.
Siemens Medical Solutions Usa, Inc.: FDA-registered device maker in Issaquah, WA, United States, 50 510(k) clearances
Siemens Medical Solutions Usa, Inc. is registered with the FDA (registration 3023245) in Issaquah, WA, United States. It lists 9 device types. The FDA files 50 510(k) clearances under its listings, the newest dated September 10, 2026. 10 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3023245
- Address
- 22010 S.E. 51st Street, Issaquah, WA, United States, 98029
- Owner or operator
- SIEMENS MEDICAL SOLUTIONS USA, INC. (9002915)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 23, 2013
- Registered through
- 2027
- Brand names listed
- ACUNAV Luxera 4D ICE Catheter, ACUSON AcuNav Volume ICE Catheter, ACUSON Antares Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System, ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System, ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Biopsy Needle Guide Kit | OIJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 10, 2026 | K261696 | ACUNAV Luxera 4D ICE Catheter | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 16, 2026 | K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 17, 2025 | K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 13, 2025 | K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 20, 2025 | K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 19, 2024 | K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 15, 2024 | K243299 | ACUSON Redwood Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 22, 2024 | K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 12, 2024 | K233613 | ACUSON SC2000 Diagnostic Ultrasound System | IYO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 12, 2024 | K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 30, 2023 | K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 28, 2023 | K233270 | AcuNav Crystal Ultrasound Catheter | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 26, 2023 | K232617 | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 13, 2023 | K230207 | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 6, 2023 | K223735 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 16, 2022 | K221190 | ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 14, 2022 | K221500 | ACUSON Sequoia Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 11, 2022 | K213487 | ACUSON P500 Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 5, 2021 | K211726 | Acuson SC2000 Diagnostic Ultrasound System | IYO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 15, 2021 | K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 20, 2021 | K211859 | ACUSON Sequoia Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 1, 2021 | K210743 | ACUSON Redwood Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 19, 2021 | K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| 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 |
| June 24, 2020 | K201462 | ACUSON Sequoia Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 26, 2020 | K201130 | ACUSON Juniper Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 22, 2020 | K200585 | Acuson SC2000 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 15, 2020 | K200707 | ACUSON Sequoia 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 |
| January 31, 2020 | K193257 | ACUSON Sequoia Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 22, 2019 | K192835 | ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 15, 2019 | K191922 | ACUSON P200 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 31, 2018 | K181098 | ACUSON SC2000 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 7, 2018 | K180067 | ACUSON X800 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 2, 2018 | K173981 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. Ultrasound Group | accessdata.fda.gov |
| February 1, 2018 | K180039 | ACUSON P600 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 19, 2017 | K173618 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 16, 2017 | K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Siemens Healthcare | accessdata.fda.gov |
| June 15, 2017 | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 4, 2017 | K163396 | ACUSON P500 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 |
| October 6, 2015 | K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. Ultrasound Group | accessdata.fda.gov |
| December 10, 2014 | K143254 | eSie Apps Suite | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 23, 2014 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 7, 2014 | K141846 | ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 22, 2012 | K121699 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 22, 2008 | K081148 | SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER | IYO | Substantially Equivalent | Siemens Medical Solutions USA, Inc., Ultrasound DI | accessdata.fda.gov |
| January 5, 2007 | K063803 | ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc., Ultrasound DI | accessdata.fda.gov |
| November 23, 2005 | K052894 | SONOLINE G60 S ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 20, 2000 | K003125 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 15, 2024 | 95254 | Class II | Ongoing | ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software. | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or | accessdata.fda.gov |
| February 23, 2024 | 94211 | Class II | Ongoing | ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively | accessdata.fda.gov |
| July 13, 2023 | 92750 | Class II | Ongoing | ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 | If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient m | accessdata.fda.gov |
| March 7, 2022 | 89856 | Class II | Ongoing | Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only | Transducers (component of ultrasound system) may exceed recommended thermal index limits | accessdata.fda.gov |
| January 19, 2022 | 89499 | Class II | Ongoing | Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediat | The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam. | accessdata.fda.gov |
| November 12, 2021 | 89139 | Class II | Ongoing | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B | Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition. | accessdata.fda.gov |
| July 12, 2021 | 88405 | Class II | Terminated | ACUSON Juniper Diagnostic Ultrasound System | Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable. | accessdata.fda.gov |
| February 4, 2021 | 87362 | Class II | Ongoing | Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems | The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births. | accessdata.fda.gov |
| May 22, 2020 | 85807 | Class II | Terminated | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F | Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block. | accessdata.fda.gov |
| September 5, 2003 | 26509 | Not yet classified | Terminated | SONOLINE Antares Diagnostic Ultrasound System. | Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Biopsy Needle Guide Kit
- All makers of System, Image Processing, Radiological
Updated September 10, 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.