# K113337: Visia Dynamic Review

- Pathway: 510(k) (Traditional)
- Applicant: MeVis Medical Solutions AG
- Decided: Dec 30, 2011 after 46 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K03003: Syngo BreVis. Number could not be read

## Indications for use
Visiam Dynamic Review is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. Visia TM Dynamic Review supports evaluation of dynamic MR data. Visia TM Dynamic Review automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics (parametric image maps). Furthermore, it performs other user-defined post-processing functions such as image subtractions; multi-planar reformats and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. Visia TM Dynamic Review can also be used to provide measurements for diameters, areas and volumes. Furthermore, Visia Dynamic Review can evaluate the uptake characteristics of segmented tissues. Visiam Dynamic Review also displays images from a number of other imaging modalities; however, these images must not be used for primary diagnostic interpretation. When interpreted by a skilled physician, Visia TM Dynamic Review provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of VisiaN Dynamic Review analysis.

Source page: https://510kreport.com/device/K113337
Methodology: https://510kreport.com/methodology