# K182938: Emission Computed Tomography System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Dec 18, 2018 after 56 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K002715 (2000). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172143: uMI 780 PET/CT System, Shanghai United Imaging Healthcare Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K231762: uEXPLORER (2024), 0 descendants of its own

## Recalls of this device
- Jul 16, 2020 · Class II · Z-2799-2020: 1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference

## Indications for use
The uEXPLORER PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images. This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Source page: https://510kreport.com/device/K182938
Methodology: https://510kreport.com/methodology