# K241596: uMI Panvivo

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Aug 15, 2024 after 73 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.
5 later devices descend from it; 1 cites it directly.
0 of 26 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
- 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
- K253564: uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (2026), 1 descendant of its own
- K261427: uMI Panvivo (uMI Panvivo M) (2026), 0 descendants of its own
- K260524: uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (2026), 0 descendants of its own

## Recalls of this device
- Aug 11, 2026 · Class II · Z-3286-2026: 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

## Indications for use
The uMI Panvivo is a PET/CT system designed for providing anatomical and functional images. The PET provides the distribution of specific radiopharmaceuticals. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. PET and CT scans can be performed separately. The system is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body. When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the uMI Panvivo system generates images depicting the distribution of these radiopharmaceuticals. The images produced by the uMI Panvivo are intended for analysis and interpretation by qualified medical professionals. They can serve as an aid in detection, localization, evaluation, diagnosis, staging, re-staging, monitoring, and/or follow-up of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or diseases, in several clinical areas such as oncology, infection and inflammation, neurology. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. The CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.* * Please refer to clinical literature, including the results of the National Lung Screening Trial (N EngI J Med 2011; 365:395-409) and subsequent literature, for further information.

Source page: https://510kreport.com/device/K241596
Methodology: https://510kreport.com/methodology