Data / Medical devices / Germany / Siemens Healthineers AG
Siemens Healthineers AG: FDA-registered device maker in ERLANGEN Bavaria, Germany, 134 510(k) clearances
Siemens Healthineers AG is registered with the FDA (registration 3002808157) in ERLANGEN Bavaria, Germany. It lists 19 device types. The FDA files 134 510(k) clearances under its listings, the newest dated September 1, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002808157
- Address
- Allee am Rothelheimpark 2, ERLANGEN Bavaria, Germany, 91052
- Owner or operator
- Siemens Healthineers AG (8010024)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- March 26, 2003
- Registered through
- 2027
- Brand names listed
- 098 1.5T Foot Ankle Coil, 098 1.5T Foot Ankle Coil Set, 1.5T Shoulder 16 Large, 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA, 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA, 6 CHANNEL BODY COIL, ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS, AI-Rad Companion (Cardiovascular) VA20 and more
Devices it lists
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. Newest 100 of 134.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2026 | K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star | LNH | Substantially Equivalent | Siemens Shenzhen Magnetic Resonance , Ltd. | accessdata.fda.gov |
| July 31, 2026 | K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | LNH | Substantially Equivalent | Siemens Healthineers AG | accessdata.fda.gov |
| June 15, 2026 | K253690 | LungMaps | QIH | Substantially Equivalent | Siemens Healthineers AG | accessdata.fda.gov |
| April 10, 2026 | K252548 | AI-Rad Companion Organs RT | QKB | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| February 23, 2026 | K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | LNH | Substantially Equivalent | Siemens Shenzhen Magnetic Resonance , Ltd. | accessdata.fda.gov |
| January 22, 2026 | K253057 | AI-Rad Companion Brain MR | QIH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| January 15, 2026 | K253023 | BIOGRAPH One | OUO | Substantially Equivalent | Siemens Healthineers AG | accessdata.fda.gov |
| December 19, 2025 | K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | LNH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| November 20, 2025 | K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | LNH | Substantially Equivalent | Siemens Shenzhen Magnetic Resonance , Ltd. | accessdata.fda.gov |
| September 9, 2025 | K252608 | AI-Rad Companion Prostate MR | LLZ | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| June 16, 2025 | K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | LNH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| June 16, 2025 | K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | LNH | Substantially Equivalent | Siemens Shenzhen Magnetic Resonance , Ltd. | accessdata.fda.gov |
| April 3, 2025 | K242551 | syngo Dynamics (Version VA41D) | QIH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| March 27, 2025 | K242745 | AI-Rad Companion Organs RT | QKB | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| April 3, 2024 | K232899 | AI-Rad Companion Organs RT | QKB | Substantially Equivalent | Siemens Medical Solutions U.S.A. | accessdata.fda.gov |
| March 29, 2024 | K240608 | MAGNETOM Viato.Mobile | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 22, 2024 | K232322 | MAGNETOM Terra; MAGNETOM Terra.X | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 21, 2024 | K233753 | AI-Rad Companion (Pulmonary) | JAK | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| February 29, 2024 | K232765 | MAGNETOM Cima.X Fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 22, 2023 | K232535 | MAGNETOM Sola; MAGNETOM Altea | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 18, 2023 | K231587 | MAGNETOM Cima.X | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 14, 2023 | K232494 | MAGNETOM Avanto fit; MAGNETOM Skyra fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 23, 2023 | K232305 | AI-Rad Companion Brain MR | QIH | Substantially Equivalent | Siemens Medical Solutions U.S.A. | accessdata.fda.gov |
| October 23, 2023 | K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 6, 2023 | K232482 | MAGNETOM Viato.Mobile | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 13, 2023 | K231351 | Chondral Quant | LLZ | Substantially Equivalent | Siemens Medical Soultions USA, Inc. | accessdata.fda.gov |
| April 6, 2023 | K222360 | AI-Rad Companion (Cardiovascular) | JAK | Substantially Equivalent | Siemens Medical Solutions U.S.A. | accessdata.fda.gov |
| February 24, 2023 | K213805 | MAGNETOM Vida | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 20, 2022 | K222361 | AI-Rad Companion (Musculoskeletal) | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 14, 2022 | K221305 | AI-Rad Companion Organs RT | QKB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 13, 2022 | K221733 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 11, 2022 | K213713 | AI-Rad Companion (Pulmonary) | JAK | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| May 13, 2022 | K220589 | MAGNETOM Skyra Fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 29, 2022 | K220939 | MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 15, 2022 | K213706 | AI-Rad Companion Brain MR | QIH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| April 1, 2022 | K220151 | MAGNETOM Avanto Fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 11, 2022 | K220425 | MAGNETOM Vida, MAGNETOM Sola | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 25, 2022 | K213693 | MAGNETOM Vida with syngo MR XA50A | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 31, 2021 | K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 6, 2020 | K193562 | AI-Rad Companion Organs RT | QKB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 8, 2020 | K202014 | Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 30, 2020 | K193283 | AI-Rad Companion Prostate MR | QIH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 10, 2020 | K193294 | AI-Rad Companion Engine | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 17, 2020 | K193290 | AI-Rad Companion Brain MR | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 11, 2020 | K200213 | Biograph mMR with syngo MR E11P-AP01 system software | OUO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 11, 2020 | K192924 | MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 28, 2020 | K192496 | Magnetom Sola, Magnetom Altea and Magnetom Sola Fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 31, 2020 | K192462 | syngo.MR Applications | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 12, 2019 | K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 5, 2019 | K182904 | syngo.MR Applications | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 31, 2019 | K190757 | MAGNETOM Avanto Fit | LNH | Substantially Equivalent | Siemens Medical Solution USA, Inc. | accessdata.fda.gov |
| February 15, 2019 | K190138 | MAGNETOM Aera | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 15, 2019 | K183222 | MAGNETOM Terra | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 24, 2019 | K183244 | MAGNETOM Lumina | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 18, 2019 | K183254 | Magnetom Vida | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 6, 2018 | K181613 | MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 26, 2018 | K182299 | MAGNETOM Aera | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 19, 2018 | K181433 | MAGNETOM Vida | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 12, 2018 | K182129 | MAGNETOM Sola | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 5, 2018 | K181322 | MAGNETOM Sola | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 19, 2018 | K180336 | syngo.MR Applications | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 30, 2018 | K173617 | MAGNETOM Vida with Compressed Sensing GRASP-VIBE | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 13, 2018 | K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 14, 2017 | K172531 | Biograph mMR with mMR Angio Transfer Option | OUO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 12, 2017 | K170840 | MAGNETOM Terra | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 14, 2017 | K170396 | MAGNETOM Vida | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 28, 2017 | K163234 | Biograph mMR with syngo MR E11P system software | OUO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 6, 2017 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 27, 2017 | K163312 | MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 22, 2016 | K162102 | MAGNETOM Avantofit, MAGNETOM Skyrafit | LNH | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| April 15, 2016 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| September 29, 2015 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 7, 2015 | K151353 | syngo.MR Neurology, syngo.MR Oncology | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 19, 2014 | K141977 | MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 8, 2014 | K142515 | MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 18, 2014 | K140897 | SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 20, 2014 | K140253 | MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 11, 2014 | K133401 | SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 12, 2013 | K133435 | MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 22, 2013 | K132119 | MAGNETOM PRISMA, MAGNETOM PRISMA FIT | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 15, 2013 | K132951 | MAGNETOM AERA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 12, 2013 | K133226 | BIOGRAPH MMR | OUO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 1, 2013 | K132831 | QUIET/SILENT SCANNING SUITE | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 20, 2013 | K130749 | SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 17, 2013 | K130885 | MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 17, 2013 | K123510 | MAGNETOM SKYRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 12, 2013 | K123938 | SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 20, 2012 | K123375 | SYNGO.VIA | LLZ | Substantially Equivalent | Siemens AG | accessdata.fda.gov |
| November 5, 2012 | K121434 | SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO | LNH | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| June 22, 2012 | K121459 | SYNGO.MR NEUROLOGY | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 13, 2012 | K120315 | SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 6, 2012 | K111861 | SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE | LLZ | Substantially Equivalent | Siemens Medical Systems USA | accessdata.fda.gov |
| November 23, 2011 | K111242 | MAGNETOM AERA AND MAGNETOM SKYRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 8, 2011 | K103429 | BIOGRAPH MMR | OUO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101347 | MAGNETOM AERA; MAGNETOM SKYRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 24, 2009 | K091546 | NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 | MOS | Substantially Equivalent | Noras Mri Products GmbH | accessdata.fda.gov |
| April 28, 2009 | K090038 | SYNGO BREVIS | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 7, 2008 | K082427 | SYNGO MR B17 | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 4, 2008 | K080072 | MRI PATIENT POSITIONING DEVICES | IYE | Substantially Equivalent | CIVCO Medical Instruments Co., Inc. | accessdata.fda.gov |
| October 10, 2007 | K072237 | MAGNETOM VERIO | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
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Updated September 1, 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.