510(k) · Cleared
ClearedBreast Immobiization and Biopsy Device MR-Biopsy 160
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Devices Corp. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Apr 9, 2001 after a 42-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 19 of the 255 devices in its family, counting itself, have a Class I recall. 254 later devices descend from it.
- Decided
- Apr 9, 2001
- Review
- 42 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
254 later devices descend from it, 6 citing it directly. 19 of the 255 devices in this family, counting this one, have a Class I recall.
- This deviceK010570 Breast Immobiization and Biopsy Device MR-Biopsy 160Mri Devices Corp. · 2001
- Descendant · cites it directly · 229 of its ownK060873 Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array…Sentinelle Medical, Inc. · 2006
- Descendant · 2 generations on · 227 of its ownK100113 Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for…Sentinelle Medical, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 220 of its ownK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 215 of its ownK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- Descendant · 5 generations on · 115 of its ownK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
Showing 5 of 254 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 254 · See all- K060873Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa SystemsSentinelle Medical, Inc. · 2006 · cites it directly229descendants
- K100113Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System…Sentinelle Medical, Inc. · 2010 · 2 generations on227descendants
- K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · 3 generations on220descendants
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 4 generations on215descendants
- K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc. · 2014 · 5 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010570 | Breast Immobiization and Biopsy Device MR-Biopsy 160 | Mri Devices Corp. | 2001 | — |
| +1 | K060873 | Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE… | Sentinelle Medical, Inc. | 2006 | — |
| +2 | K100113 | Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri… | Sentinelle Medical, Inc. | 2010 | 1 |
| +3 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| +4 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| +5 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 1 |
| 2013 | 12 | 2 |
| 2014 | 9 | 0 |
| 2015 | 7 | 1 |
| 2016 | 5 | 1 |
| 2017 | 16 | 1 |
| 2018 | 20 | 2 |
| 2019 | 21 | 1 |
| 2020 | 22 | 3 |
| 2021 | 10 | 1 |
| 2022 | 24 | 2 |
| 2023 | 28 | 3 |
| 2024 | 20 | 0 |
| 2025 | 21 | 1 |
| 2026 | 22 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
19 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (254)
See all 2546 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060873 | Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems | 2006 | 229 |
| K041286 | Dynacad V1.0 | 2004 | 17 |
| K020289 | Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias | 2002 | 3 |
| K052987 | Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI 160-CC | 2005 | 2 |
| K081118 | Noras MR-BI320-PA 1.5T | 2008 | 0 |
| K023686 | Aurora MR-Guided Interventional System | 2003 | 0 |
Has anything in its family been recalled? (19 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc. · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc. · 2018 · 7 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
- K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc. · 2019 · 9 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · 10 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 19 shown.
Nearest 5 of 19; all are on the web page.
What does this lineage say?
- Of its descendants, K060873 (Sentinelle Medical, Inc., 2006) has gone furthest, with 229 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
https://510kreport.com/device/K010570 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010570: Breast Immobiization and Biopsy Device MR-Biopsy 160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010570
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026