# K063031: Prism View, Model

- Pathway: 510(k) (Special)
- Applicant: Kyron Clinical Imaging, Inc.
- Decided: Nov 2, 2006 after 30 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: 5 generations back to K954678 (1996). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052467: Brain Viewrx Viewer, Version 1.0, Kyron Clinical Imaging, Inc. (2005) Summary page 1.

## Most influential descendants
- K082964: Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5) (2009), 1 descendant of its own
- K122026: Prism Acquire Prism Process Prism View (2012), 0 descendants of its own

## Indications for use
Prism View™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

Source page: https://510kreport.com/device/K063031
Methodology: https://510kreport.com/methodology