# K113701: Visia Neuro

- Pathway: 510(k) (Traditional)
- Applicant: MeVis Medical Solutions AG
- Decided: Feb 16, 2012 after 62 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913475 (1991). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081262: DC Neuro, Invivo Corporation (2008) Summary page 3.

## Most influential descendants
- K141514: Synapse 3D Tensor Analysis (2014), 0 descendants of its own

## Indications for use
Visia7 N Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visia TM Neuro provides both analysis and viewing capabilities for anatomical and physiologic/functional imaging datasets, including blood oxygen dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic review, and vessel visualization. Data can be visualized in both 2D and 3D views. BOLD fMRI Review The BOLD ftvlRl feature is useful in identifying small susceptibility changes arising from neuronal activity during performance of a specific task. Diffusion Review The diffusion review feature is intended for visualization and analysis of the diffusion of water molecules through brain tissue. Fiber Tracking Review The fiber tracking feature uses the directional portion of the diffusion vector to track and visualize white matter structures within the brain. Dynamic Review Dynamic review feature is intended for visualization and analysis of MRI dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary. Vessel Visualization The vessel feature is used to identify and visualize the vascular structures of the brain. 3D Visualization The 3D visualization feature allows image data to be reconstructed as 3D objects that are visualized and manipulated on a 2D screen.

Source page: https://510kreport.com/device/K113701
Methodology: https://510kreport.com/methodology