# K072841: Neuviz Spiral CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Oct 16, 2007 after 12 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: 1 generation back to K020913 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020913: CT-C3000 Spiral CT Scanner System, Neusoft Digital Medical Systems Co., Ltd. (2002) 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. This device will not be used for breast disease diagnoses.

Source page: https://510kreport.com/device/K072841
Methodology: https://510kreport.com/methodology