# K172143: uMI 780 PET/CT System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Apr 13, 2018 after 270 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K002715 (2000). 19 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151486: Biograph mCT and mCT Flow PET/CT Scanners, Siemens Medical Solutions USA, Inc. (2015) Summary page 7.

## Most influential descendants
- K241596: uMI Panvivo (2024), 5 descendants of its own
- K243538: uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (2024), 4 descendants of its own
- K251839: uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (2025), 3 descendants of its own
- K223325: uMI Panorama (2023), 3 descendants of its own
- K182237: uMI 550 PET/CT System (2018), 3 descendants of its own

## Recalls of this device
- Aug 11, 2026 · Class II · Z-3288-2026: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents
- Sep 12, 2025 · Class II · Z-0224-2026: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

## Indications for use
The uMI 780 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/K172143
Methodology: https://510kreport.com/methodology