# K192630: uWS-MI

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Jun 11, 2020 after 262 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: 12 generations back to K913770 (1991). 182 ancestors in all.
1 later device descends 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)
- K172998: uWS-MI, Shanghai United Imaging Healthcare Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- 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 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 Dynamic Analysis application is intended to display PET data and anatomical data such as CT or MR, and supports to do lesion segmentation and output associated time-activity curve. The 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 or between two studies from the same patient, as well as provide analysis of amyloid uptake levels in the brain. The 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/K192630
Methodology: https://510kreport.com/methodology