# K090173: Neuviz 16 Multi-Slice CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Feb 5, 2009 after 13 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: 4 generations back to K930090 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012009: MX8000 Idt CT System, Marconi Medical Systems, Inc. (2001) Summary page 3.

## Recalls of this device
- Mar 24, 2016 · Class II · Z-1573-2016: The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for c
- Mar 4, 2013 · Class II · Z-1165-2013: User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another pe
- Oct 18, 2012 · Class II · Z-0466-2013: The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
- Jun 8, 2012 · Class II · Z-2083-2012: One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.
- Feb 9, 2011 · Not classified · Z-2241-2011: Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image.

## Indications for use
The NeuViz 16 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 with multislice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional imagers of the body from the same axial plane taken at different angles. The system is suitable for all patients.

Source page: https://510kreport.com/device/K090173
Methodology: https://510kreport.com/methodology