# K182237: uMI 550 PET/CT System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Oct 12, 2018 after 56 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 10 (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.
3 later devices descend from it; 2 cite it directly.
0 of 24 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
- K193241: Emission Computed Tomography System (2020), 1 descendant of its own
- K210001: HYPER AiR (2021), 0 descendants of its own
- K193210: Hyper DLR (2020), 0 descendants of its own

## Recalls of this device
- Aug 11, 2026 · Class II · Z-3283-2026: 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-0223-2026: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
- Mar 1, 2023 · Class II · Z-1353-2023: Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET 
- May 30, 2022 · Class II · Z-0087-2023: The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respi
- Aug 2, 2021 · Class II · Z-2594-2021: The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
- Aug 2, 2021 · Class II · Z-2593-2021: The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
- Aug 5, 2020 · Class II · Z-0448-2021: A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessar
- Jul 16, 2020 · Class II · Z-2800-2020: 1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external int
- Mar 26, 2020 · Class II · Z-2819-2020: In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the 
- Aug 26, 2019 · Class II · Z-1708-2020: Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly ca

## Indications for use
The uMI 550 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/K182237
Methodology: https://510kreport.com/methodology