# K242624: Medical Image Post-processing Software (uOmnispace.CT)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: May 14, 2025 after 253 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 14 generations back to K913770 (1991). 187 ancestors in all.
No later device cites it as a predicate yet.
3 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233209: uOmnispace.CT, Shanghai United Imaging Healthcare Co., Ltd. (2024) Summary page 6.
- K193289: FastStroke, CT Perfusion 4D, GE Medical Systems SCS (2020) Summary page 6.

## Indications for use
uOmnispace.CT is a software for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The uOmnispace.CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon. The uOmnispace.CT Dental Application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. The uOmnispace.CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway. The uOmnispace.CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. The uOmnispace.CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images. The uOmnispace.CT Brain Perfusion application is intended to calculate the parameters such as: CBYV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in brain. The uOmnispace.CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function. The uOmnispace.CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score. The uOmnispace.CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes. The uOmnispace.CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk. The uOmnispace.CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation. The uOmnispace.CT Dual Energy is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The Dual Energy application is intended to provide information on the chemical composition of the scanned body materials and/or contrast agents. Additionally, it enables images to be generated at multiple energies within the available spectrum. The uOmnispace.CT Cardiovascular Combined Analysis is an image analysis software package for evaluating contrast enhanced CT images. The CT Cardiovascular Combined Analysis is intended to analyze vascular and cardiac structures.It can be used in the qualitative and quantitative for the analysis of head-neck, abdomen, multi-body part combined, TAVR (Transcatheter Aortic Valve Replacement) CT data as input for the planning of cardiovascular procedures. The uOmnispace.CT Body Perfusion is intended to analyze blood flow information of dynamic CT Images, by providing various perfusion-related parameters of the body parts.

Source page: https://510kreport.com/device/K242624
Methodology: https://510kreport.com/methodology