# K020913: CT-C3000 Spiral CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Digital Medical Systems Co., Ltd.
- Decided: Apr 3, 2002 after 13 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041542: CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner Systems (2004), 3 descendants of its own
- K062451: Neuviz Dual Multi-Slice CT Scanner System (2006), 2 descendants of its own
- K071308: Modification to Neuviz Dual Multi-Slice CT Scanner System (2007), 1 descendant of its own
- K080540: Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0 (2008), 0 descendants of its own
- K072841: Neuviz Spiral CT Scanner System (2007), 0 descendants of its own

## Indications for use
CT-C3000 System is 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/K020913
Methodology: https://510kreport.com/methodology