Devices descending from K010570
254 later devices reach Breast Immobiization and Biopsy Device MR-Biopsy 160 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K081118 | Noras MR-BI320-PA 1.5T | Noras Mri Products GmbH | 2008 | 0 | — |
| +1 | K060873 | Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems | Sentinelle Medical, Inc. | 2006 | 229 | — |
| +1 | K052987 | Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI 160-CC | Noras Rontgen-Und Medizintechnik GmbH | 2005 | 2 | — |
| +1 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | 17 | — |
| +1 | K023686 | Aurora MR-Guided Interventional System | Aurora Imaging Technology, Inc. | 2003 | 0 | — |
| +1 | K020289 | Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias | Machnet BV | 2002 | 3 | — |
| +2 | K191959 | QuantX Breast MRI Biopsy Guidance Plugin | Qlarity Imaging | 2019 | 0 | — |
| +2 | K173744 | ProFuse CAD | Eigen | 2018 | 1 | — |
| +2 | K142002 | Breast Speeder CX, Grid Holder CX | Quality Electrodynamics, LLC | 2014 | 0 | — |
| +2 | K133030 | Dynacad/Prostate Interventional (Dynaloc/Prostate) | Invivo Corporation | 2014 | 1 | 1 |
| +2 | K130262 | Magnetom Essenza with Syngo MR D14 | Siemens Medical Solutions USA, Inc. | 2013 | 11 | — |
| +2 | K100113 | Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System… | Sentinelle Medical, Inc. | 2010 | 227 | 1 |
| +2 | K090038 | Syngo Brevis | Siemens Medical Solutions USA, Inc. | 2009 | 0 | — |
| +2 | K090223 | Icad Breast Interventional Planning Software, Model D70024 | Icad, Inc. | 2009 | 0 | 1 |
| +2 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | 9 | — |
| +2 | K071534 | Confirma Breast Mri Interventional Components | Confirma, Inc. | 2007 | 0 | — |
| +2 | K041020 | Cadstream Version 3.1 | Confirma, Inc. | 2004 | 0 | — |
| +3 | K223484 | IGAR System (1001.A) | Insight Medbotics, Inc. | 2023 | 0 | — |
| +3 | K191278 | Rsi-Mri+ | Multimodal Imaging Services Corporation (Dba Healthlytix) | 2019 | 0 | — |
| +3 | K173312 | ProBx Software | Harmonus, Inc. | 2018 | 0 | — |
| +3 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | 4 | — |
| +3 | K161795 | Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2016 | 0 | — |
| +3 | K152283 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2015 | 9 | — |
| +3 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 220 | 3 |
| +3 | K112112 | Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T Mri Systems | Sentinel Medical, Inc. | 2011 | 4 | — |
| +3 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 8 | 3 |
| +4 | K231130 | TumorSight Viz | SimBioSys, Inc. | 2023 | 2 | — |
| +4 | K213735 | dS Sentinelle Breast 16ch 1.5T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022 | 2 | — |
| +4 | K213727 | dS Sentinelle Breast 16ch 3.0T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022 | 1 | — |
| +4 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | 3 | — |
| +4 | K173600 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2017 | 7 | — |
| +4 | K163211 | MAGNETOM Sempra with syngo MR E11S | Siemens Medical Solutions USA, Inc. | 2017 | 7 | — |
| +4 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | 215 | Class I |
| +4 | K121459 | Syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2012 | 3 | — |
| +5 | K260086 | CadAI-B Dx | BeamWorks, Inc. | 2026 | 0 | — |
| +5 | K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil… | Philips Medical Systems Nederland B.V. | 2026 | 0 | — |
| +5 | K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | 2026 | 0 | — |
| +5 | K243189 | TumorSight Viz | SimBioSys, Inc. | 2024 | 1 | — |
| +5 | K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pte, Ltd. | 2024 | 0 | — |
| +5 | K233348 | 16 Breast Coil | Philips Medical System Nederlands B.V. | 2023 | 0 | — |
| +5 | K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease… | Siemens Medical Solutions USA, Inc. | 2019 | 0 | — |
| +5 | K183221 | MAGNETOM Amira, MAGNETOM Sempra | Siemens Medical Solutions USA, Inc. | 2019 | 6 | 1 |
| +5 | K181613 | MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D | Siemens Medical Solutions USA, Inc. | 2018 | 0 | Class I |
| +5 | K163234 | Biograph mMR with syngo MR E11P system software | Siemens Medical Solutions USA, Inc. | 2017 | 12 | — |
| +5 | K152602 | Olea Sphere V3.0 | Olea Medical | 2016 | 17 | — |
| +5 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A… | Siemens Medical Solutions USA, Inc. | 2014 | 115 | — |
| +5 | K140666 | MR Elastography | Philips Medical Systems Nederland B.V. | 2014 | 2 | — |
| +5 | K140253 | Magnetom Artis Combi Suite for the Magnetom Aera/Skyra/Skyra with Timtx Trueshape | Siemens Medical Solutions USA, Inc. | 2014 | 1 | — |
| +5 | K131447 | Intuition - Tda, Tva, Parametric Mapping | Terarecon,Inc. | 2013 | 2 | — |
| +5 | K133435 | Magnetom Aera and Skyra with Software MR D13A | Siemens Medical Solutions USA, Inc. | 2013 | 0 | — |
| +5 | K132951 | Magnetom Aera | Siemens Medical Solutions USA, Inc. | 2013 | 9 | 1 |
| +5 | K132831 | Quiet/Silent Scanning Suite | Siemens Medical Solutions USA, Inc. | 2013 | 0 | — |
| +5 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | 54 | — |
| +5 | K123510 | Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2013 | 16 | — |
| +5 | K130885 | Magnetom Avanto-Fit, Magnetom Skyra-Fit | Siemens Medical Solutions USA, Inc. | 2013 | 0 | Class I |
| +5 | K123938 | Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for… | Siemens Medical Solutions USA, Inc. | 2013 | 38 | — |
| +5 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | 63 | — |
| +6 | K253963 | Cubresa BrainPET | Cubresa, Inc. | 2026 | 0 | — |
| +6 | K243681 | Neuro Insight V1.0 | Olea Medical S.A.S. | 2025 | 0 | — |
| +6 | K251766 | TumorSight Viz | SimBioSys, Inc. | 2025 | 0 | — |
| +6 | K242006 | SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC | 2025 | 0 | — |
| +6 | K231133 | neo315 | Neoscan Solution GmbH | 2024 | 0 | — |
| +6 | K223091 | CT Perfusion V1.0 | Olea Medical | 2023 | 0 | — |
| +6 | K223532 | Olea S.I.A. Neurovascular V1.0 | Olea Medical | 2023 | 1 | — |
| +6 | K230552 | MR DWI/FLAIR Measurement V1.0 | Olea Medical | 2023 | 0 | — |
| +6 | K211059 | CereFlow™ V1.2 | Translational Mri, LLC | 2023 | 1 | — |
| +6 | K223343 | MAGNETOM Amira; MAGNETOM Sempra | Siemens Medical Solutions USA, Inc. | 2023 | 0 | 1 |
| +6 | K223502 | MR Diffusion Perfusion Mismatch V1.0 | Olea Medical | 2023 | 0 | — |
| +6 | K212565 | CoverScan v1 | Perspectum, Ltd. | 2022 | 1 | — |
| +6 | K220018 | MR Elastography; MZEK-001A | Canon Medical Systems Corporation | 2022 | 0 | — |
| +6 | K210611 | MAGNETOM Free.Max | Siemens Medical Solutions USA, Inc. | 2021 | 4 | 1 |
| +6 | K203582 | QUIBIM Precision Prostate (qp-Prostate) | Quibim S.L. | 2021 | 1 | — |
| +6 | K203216 | The Multimodality Advanced Vessel Analysis | Philips Medical Systems Nederland B.V. | 2020 | 1 | — |
| +6 | K200750 | Neuro.Al Algorithm | Terarecon,Inc. | 2020 | 1 | — |
| +6 | K200213 | Biograph mMR with syngo MR E11P-AP01 system software | Siemens Medical Solutions USA, Inc. | 2020 | 1 | Class I |
| +6 | K182716 | Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. | 2019 | 1 | — |
| +6 | K173001 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 5 | — |
| +6 | K172999 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 4 | — |
| +6 | K181370 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 11 | — |
| +6 | K180926 | uMR 560 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 0 | — |
| +6 | K180925 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 7 | — |
| +6 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | 21 | — |
| +6 | K172998 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 2 | — |
| +6 | K173625 | syngo.CT Clinical Extensions | Siemens Medical Solutions USA, Inc. | 2018 | 5 | — |
| +6 | K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2018 | 7 | — |
| +6 | K173467 | Advanced Diffusion Analysis (ADA) application | Philips Medical Systems Nederland B.V. | 2017 | 0 | — |
| +6 | K172531 | Biograph mMR with mMR Angio Transfer Option | Siemens Medical Solutions USA, Inc. | 2017 | 0 | — |
| +6 | K170840 | MAGNETOM Terra | Siemens Medical Solutions USA, Inc. | 2017 | 2 | — |
| +6 | K170580 | Carestream Vue PACS | Carestream Health, Inc. | 2017 | 1 | — |
| +6 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | 23 | — |
| +6 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | 2016 | 84 | Class I |
| +6 | K153447 | MAGNETOM Spectra | Siemens Medical Solutions USA, Inc. | 2016 | 0 | 1 |
| +6 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma… | Siemens Medical Solutions USA, Inc. | 2015 | 85 | Class I |
| +6 | K143020 | LiverMultiScan | Mirada Medical, Ltd. | 2015 | 8 | — |
| +6 | K150069 | Fine Structure Analysis (fineSA) | Acuitas Medical, Ltd. | 2015 | 0 | — |
| +6 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | 46 | — |
| +6 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | 1 | — |
| +6 | K142515 | MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite… | Siemens Medical Solutions USA, Inc. | 2014 | 0 | — |
| +6 | K133401 | Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General | Siemens Medical Solutions USA, Inc. | 2014 | 27 | — |
| +6 | K132119 | Magnetom Prisma, Magnetom Prisma Fit | Siemens Medical Solutions USA, Inc. | 2013 | 12 | Class I |