# K121075: Nervevision Software Systems

- Pathway: 510(k) (Traditional)
- Applicant: 3D Imaging Partners, Inc.
- Decided: Jul 26, 2012 after 108 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: 8 generations back to K954678 (1996). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111311: Segmentation Assistant for Prostate-Auto Contouring, Omisa Inc. (Segasist Technologies) (2011) Summary page 1.

## Indications for use
The NERVEVISION SOFTWARE SYSTEMS is a stand-alone software application to assist clinicians in segmenting and visualizing nerve anatomy from magnetic resonance images.

Source page: https://510kreport.com/device/K121075
Methodology: https://510kreport.com/methodology