# K121792: Neuviz 64 Multi-Slice CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Nov 16, 2012 after 141 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982349 (1998). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K040665: Somatom Sensation 64 and Sensation Cardiac, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.
- K092742: Neuviz 16 Multi-Slice CT Scanner System, Neusoft Medical Systems Co., Ltd. (2009) Summary page 2.

## Most influential descendants
- K133373: Clearview (2014), 0 descendants of its own

## Recalls of this device
- Oct 22, 2018 · Class II · Z-1279-2019: Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the co
- Aug 31, 2016 · Class II · Z-0876-2017: The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restar
- Aug 31, 2016 · Class II · Z-0875-2017: The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restar
- May 2, 2015 · Class II · Z-1650-2016: It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner po
- Mar 8, 2014 · Class II · Z-1693-2015: The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation and as a result h

## Indications for use
The NeuViz 64 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

Source page: https://510kreport.com/device/K121792
Methodology: https://510kreport.com/methodology