# K233176: uOmnispace.MI

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Dec 20, 2023 after 83 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: 13 generations back to K913770 (1991). 183 ancestors in all.
No later device cites it as a predicate yet.
3 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192630: uWS-MI, Shanghai United Imaging Healthcare Co., Ltd. (2020) Summary page 4.

## Indications for use
uOmnispace.MI is a software solution intended to be used for viewing, processing, evaluating and analyzing of PET, CT, MR, SPECT images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: ■ uOmnispace.MI MM Fusion application is intended to provide tools for viewing, analyzing and reporting PET, CT, MR, SPECT data with its flexible workflow and optimized layout protocols for dedicated reporting purposes on oncology, neurology, cardiology. ■ uOmnispace.MI MM Oncology application is intended to provide tools to display and analyze the follow-up PET, CT, MR data, with which users can do image registration, lesion segmentation, and statistical analysis. ■ uOmnispace.MI 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. ■ uOmnispace.MI NeuroQ application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 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. ■ uOmnispace.MI Emory Cardiac Toolbox 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/K233176
Methodology: https://510kreport.com/methodology