# K172998: uWS-MI

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Apr 5, 2018 after 190 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 181 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123920: Syngo.Via, Siemens AG Medical Solutions (2013) Summary page 5.

## Most influential descendants
- K192630: uWS-MI (2020), 1 descendant of its own
- K233176: uOmnispace.MI (2023), 0 descendants of its own

## Indications for use
uWS-MI is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The PET/CT Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis. The PET/CT Dynamic Analysis application is intended to display the dynamic PET image data and its associated time-activity curve. The PET/CT Brain Analysis (NeuroQ™) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database. The PET/CT Cardiac Analysis (ECTb™) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis, activity analysis and cardiac function analysis of the cardiac short axis.

Source page: https://510kreport.com/device/K172998
Methodology: https://510kreport.com/methodology