# K080540: Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Mar 13, 2008 after 15 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930090 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071308: Modification to Neuviz Dual Multi-Slice CT Scanner System, Neusoft Medical Systems Co., Ltd. (2007) Summary page 2.

## Indications for use
The NeuViz Spiral CT Scanner Systems are intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.

Source page: https://510kreport.com/device/K080540
Methodology: https://510kreport.com/methodology