# K052305: Mri Soft Tissue Motion Correction Software VA10A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 8, 2005 after 15 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913770 (1991). 17 ancestors in all.
34 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043216: Cadstream Version 4.0, Confirma, Inc. (2005) Summary page 1.
- K020546: Fusion 7D, Mirada Solutions, Ltd. (2002) Summary page 1.
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K073373: Syngo Volume Perfusion-CT Body (2007), 33 descendants of its own
- K122909: Syngo Single Source Dual Engery (2012), 13 descendants of its own
- K133677: Syngo CT Single Source Dual Energy (2014), 12 descendants of its own
- K150745: syngo.CT Single Source Dual Energy (2015), 11 descendants of its own
- K090504: CSBP-001A Body Perfusion System (2009), 10 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K052305
Methodology: https://510kreport.com/methodology