Data / Medical devices / South Korea / Siemens Healthineers Ltd.
Siemens Healthineers Ltd.: FDA-registered device maker in Pohang-si Gyeongbuk, South Korea, 74 510(k) clearances
Siemens Healthineers Ltd. is registered with the FDA (registration 3006985147) in Pohang-si Gyeongbuk, South Korea. It lists 8 device types. The FDA files 74 510(k) clearances under its listings, the newest dated September 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006985147
- Address
- 2nd, 3rd and 4th Venture Building Pohang Technopark, 394, Jigok-ro, Nam-gu, Pohang-si Gyeongbuk, South Korea, 37668
- Owner or operator
- SIEMENS MEDICAL SOLUTIONS USA, INC. (9002915)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 23, 2008
- Registered through
- 2026
- Brand names listed
- ACUNAV Luxera 4D ICE Catheter, ACUSON AcuNav Diagnostic Catheter, ACUSON AcuNav V Diagnostic Ultrasound Catheter, ACUSON AcuNav Volume ICE Catheter, ACUSON Adara Diagnostic Ultrasound System, ACUSON Antares Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System, ACUSON G20 Diagnostic Ultrasound System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Biopsy Needle Guide Kit | OIJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| February 1, 2018 | K173957 | ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE 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 |
| August 15, 2017 | K172374 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 12, 2017 | K171766 | Acuson SC2000 Diagnostic Ultrasound System | IYO | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| June 15, 2017 | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 4, 2017 | K170315 | Acuson SC2000 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| February 9, 2017 | K163478 | AcuNav Volume ICE Catheter | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 12, 2017 | K163635 | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. Ultrasound Group | accessdata.fda.gov |
| January 4, 2017 | K163396 | ACUSON P500 Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 6, 2016 | K162221 | ACUSON SC2000 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions Inc. Ultrasound Group | accessdata.fda.gov |
| July 28, 2016 | K161787 | ACUSON NX2 Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | Siemens Medical Solutions USA, 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 |
| September 21, 2015 | K152469 | ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions, Inc., Ultrasound Division | accessdata.fda.gov |
| February 9, 2015 | K150050 | ACUSON P500 Diagnostic Ultrasound System | IYN | 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 |
| October 10, 2014 | K142628 | Acuson SC2000 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| September 9, 2014 | K142395 | SC2000 and ACUSON X300 Diagnostic Ultrasound Systems | IYO | 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 |
| September 26, 2013 | K132654 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. Ultrasound Gro | accessdata.fda.gov |
| March 25, 2013 | K130754 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| December 5, 2012 | K123622 | ACUSON | 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 |
| June 22, 2012 | K121646 | ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. Ultrasound Gro | accessdata.fda.gov |
| December 7, 2011 | K113179 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc., Ultrasound DI | accessdata.fda.gov |
| September 20, 2010 | K102017 | SC2000 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 |
| September 26, 2008 | K081808 | ACUNAV V ULTRASOUND CATHETER | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 17, 2007 | K072365 | SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc., Ultrasound DI | accessdata.fda.gov |
| June 29, 2007 | K071234 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 22, 2007 | K071314 | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS | IYO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | 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 |
| January 4, 2007 | K063761 | ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 23, 2005 | K052894 | SONOLINE G60 S ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 15, 2004 | K042593 | ACUSON ACUNAV 8F ULTRASOUND CATHETER | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 24, 2004 | K033650 | ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 28, 2004 | K040060 | SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS | 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 |
| October 3, 1995 | K946179 | SIEMENS SONOLINE 4XX | IYO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Catheter, Ultrasound, Intravascular
- 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 Automated Radiological Image Processing Software
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.