# K110077: Neucoloncare

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Jan 28, 2011 after 17 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920950 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070831: Voxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion, Barcoview Mis Edinburgh (2007) Summary page 2.
- K032096: Philips Viewforum 2003, Philips Medical Systems (2003) Summary page 2.

## Indications for use
The NeuColonCARE is a soft-copy reading workstation intended for clinical review of CT abdominal (gastrointestinal) images which allows easy acquisition, transmission and review of the medical images and supports VC (Virtual Colonoscopy) function. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K110077
Methodology: https://510kreport.com/methodology