510(k) · Cleared
ClearedMri Soft Tissue Motion Correction Software VA10A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 8, 2005 as substantially equivalent to K043216 (Confirma, Inc., 2005) and 2 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1991. 34 later devices descend from it.
- Decided
- Sep 8, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K913770 (1991). 17 ancestors in all. 34 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- This deviceK052305 Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc. · 2005
- Descendant · cites it directly · 33 of its ownK073373 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2007
- Descendant · 2 generations on · 13 of its ownK122909 Syngo Single Source Dual EngerySiemens Medical Systems, Inc. · 2012
- Descendant · 3 generations on · 12 of its ownK133677 Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2014
- Descendant · 4 generations on · 11 of its ownK150745 syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015
- Descendant · 2 generations on · 10 of its ownK090504 CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation · 2009
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2007 · cites it directly33descendants
- K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc. · 2012 · 2 generations on13descendants
- K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2014 · 3 generations on12descendants
- K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015 · 4 generations on11descendants
- K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation · 2009 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| 0 (this device) | K052305 | Mri Soft Tissue Motion Correction Software VA10A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +1 | K073373 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2007 | — |
| +2 | K122909 | Syngo Single Source Dual Engery | Siemens Medical Systems, Inc. | 2012 | — |
| +3 | K133677 | Syngo CT Single Source Dual Energy | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +4 | K150745 | syngo.CT Single Source Dual Energy | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +2 | K090504 | CSBP-001A Body Perfusion System | Toshibamedical Systems Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNH? 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043216 | Cadstream Version 4.0Summary page 1…(21 CFR 892.2050) Product Code LLZ: ImagePoesigSse Substantial Equivalence CADstream v.4.0 K043216 Confirmanc Fusion 7D K020546 Mirada Solutions Ltd.… | 2005 |
| * | K020546 | Fusion 7DSummary page 1…ubstantial Equivalence CADstream v.4.0 K043216 Confirmanc Fusion 7D K020546 Mirada Solutions Ltd. (Now Siemen… | 2002 |
| * | K040970 | LeonardoSummary page 1…s, Inc.) Leonardo K040970 Siemens M~edicajlu ________ ______ ___ ~ ~ ~ ISolutions USA, I… | 2004 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073373 | Syngo Volume Perfusion-CT Body | 2007 | 33 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K073373 (Siemens AG Medical Solutions, 2007) has gone furthest, with 33 descendants of its own.
- 8 other devices also cite its predicate K043216.
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 | — |
What is it indicated for?
The MRI Soft Tissue Motion Correction Software is an adjunctive tool to assist radiologists in interpreting magnetic resonance imaging (MRI) studies. The software is intended to be used in dynamic MRI examinations that consist of multiple image volumes where patient motion may have occurred between serial acquisitions. The MRI Soft Tissue Motion Correction Software performs automatic 2D and/or 3D flexible registration of soft tissue. The registration…
Read the full statement (129 words)
The MRI Soft Tissue Motion Correction Software is an adjunctive tool to assist radiologists in interpreting magnetic resonance imaging (MRI) studies. The software is intended to be used in dynamic MRI examinations that consist of multiple image volumes where patient motion may have occurred between serial acquisitions.
The MRI Soft Tissue Motion Correction Software performs automatic 2D and/or 3D flexible registration of soft tissue. The registration process enables the correction of motion occuring both within-plane and across planes (3D). By aligning corresponding voxels, the software reduces the impact of patient motion in post-processing techniques including difference (subtraction) images, parametric displays, subtraction volume MIPs and mean-curve analysis.
Patient management decisions should not be made solely on the basis of motion corrected images and should always include review of uncorrected images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052305: Mri Soft Tissue Motion Correction Software VA10A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052305
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026