# K151403: Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Nov 2, 2015 after 160 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010641 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050559: GE Discovery VCT System, GE Medical Systems (2005) Summary page 5.

## Indications for use
The NeuSight PET/CT Scanner System can be used for the functional and anatomical imaging of human bodies and organs. The device is intended for whole body or regional tumor examination, cardiac examination and head examination. The device can assist in radiotherapy planning and be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system. Trained doctors can read useful diagnostic information from the image generated.

Source page: https://510kreport.com/device/K151403
Methodology: https://510kreport.com/methodology