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uOmniscan is a software application for providing real-time communication between remote and local users, providing remote read-only or fully controlled access to connected medical imaging devices, including the ability to remotely initiate MR scans. It is also used for training medical personnel in the use of medical imaging devices. It is a vendor-neutral solution. Access must be authorized by the onsite user operating the system. Images reviewed remotely are not for diagnostic use.

uOmniscan is a medical software designed to address the skill differences among technicians and their need for immediate support, allowing them to interact directly with remote experts connected to the hospital network. By collaboration between on-site technicians and remote experts, it enables technicians or radiologists located in different geographic areas to remotely assist in operating medical imaging devices. uOmniscan provides healthcare professionals with a private, secure communication platform for real-time image viewing and collaboration across multiple sites and organizations. uOmniscan establishes remote connections with Modality through application, KVM (Keyboard, Video, Mouse) switch, or UIH's proprietary access tool uRemote Assistant. The connection can be made in full control or read-only mode, assisting on-site technicians in seeking guidance and real-time support on scan-related issues, including but not limited to training, protocol evaluation, and scan parameter management, with the capability to remotely initiate scans for MR imaging equipment. In addition to supporting remote access and control of modality scanners, uOmniscan also supports common communication methods including real-time video, as well as audio calls and text chats between users. Images viewed remotely are not for diagnostic purposes. It is a vendor-neutral solution compatible with existing multimodality equipment in healthcare networks, allowing healthcare professionals to share expertise and increase work efficiency, while enhancing the communication capabilities among healthcare professionals at different locations.

The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards. This traditional 510(k) is to request modifications for the cleared uMR Omega(K240540). The modifications performed on the uMR Omega in this submission are due to the following changes that include: 1. **Addition of RF coils and corresponding accessories:** Breast Coil - 12, Biopsy Configuration, Head Coil - 16, Positioning Couch-top, Coil Support, Tx/Rx Head Coil. 2. **Modification of the mmw component name:** from mmw100 to mmw101. 3. **Modification of the dimensions of detachable table:** from width 826mm, height 880mm, length 2578mm to width 810mm, height 880mm, length 2505mm. 4. **Addition and modification of pulse sequences:** - a) New sequences: gre_pass, gre_mtp, epi_dti_msh, gre_fsp_c(3D LGE). - b) Added Associated options for certain sequences: fse(MicroView), fse_mx(MicroView), gre(Output phase image), gre_swi(QSM), gre_fsp_c(DB/GB PSIR), gre_bssfp(TI Scout), gre_bssfp_ucs(Real Time Cine), epi_dwi(IVIM), epi_dti(DSI, DKI). - c) Added Additional accessory equipment required for certain sequences: gre_bssfp (Virtual ECG Trigger). - d) Added applicable body parts: epi_dwi_msh, gre_fine, fse_mx. 5. **Addition of imaging processing methods:** Inline Cardiac function, Inline ECV, Inline MRS, Inline MOCO and MTP. 6. **Addition of workflow features:** EasyFACT, TI Scout, EasyCrop, ImageGuard, MoCap and Breast Biopsy. 7. **Addition of image reconstruction methods:** SparkCo. 8. **Modification of function:** uVision (add Body Part Recognization), EasyScan(add applicable body parts). The modification does not affect the intended use or alter the fundamental scientific technology of the device.

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: CBV, 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.

The uOmnispace.CT is a post-processing software based on the uOmnispace platform for viewing, manipulating, evaluating and analyzing medical images, can run alone or with other advanced commercially cleared applications. uOmnispace.CT contains the following applications: - uOmnispace.CT Calcium Scoring - uOmnispace.CT Lung Nodule - uOmnispace.CT Colon Analysis - uOmnispace.CT Lung Density Analysis - uOmnispace.CT Dental Application - uOmnispace.CT Bone Structure Analysis - uOmnispace.CT Dual Energy - uOmnispace.CT Vessel Analysis - uOmnispace.CT Heart - uOmnispace.CT Brain Perfusion - uOmnispace.CT Dynamic Analysis - uOmnispace.CT Liver Evaluation - uOmnispace.CT Cardiovascular Combined Analysis - uOmnispace.CT Body Perfusion The modifications performed on the uOmnispace.CT (K233209) in this submission is due to the following changes that include: - Add new application of Body Perfusion. - Extend intended patient population for some applications - Introduce deep-learning algorithm in applications of Lung Density Analysis, Vessel Analysis, Heart, Liver Evaluation and Cardiovascular Combined Analysis. These modifications do not affect the intended use or alter the fundamental scientific technology of the device

uWS-Angio Basic is intended to display and process XA (X-Ray Angiographic), CT (Computed Tomography), and MR (Magnetic Resonance) images that comply with the DICOM3.0 protocol.

uWS-Angio Basic is an image processing software that matches the use of medical vascular angiography X-ray machines. It contains the following functions: - Patient Administration - Review 2D: This application can be used to load 2D images and perform related processing. The function provides Basic processing tools for 1) 2D image viewing, 2) 2D image processing, 3) 2D DSA image viewing and processing, 4) Calibration and Measurement. - Review 3D: This application can be used for loading and processing 3D data. The function provides Basic processing tools for 1) 3D image viewing; 2) 3D image processing; 3) CTA bone removal. - Saving - Filming uWS-Angio Basic can be deployed on independent hardware such as a stand-alone diagnostic review and post processing workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, it can be deployed on systems of the United-imaging Angiography system family.

The uCT 550 is a computed tomography X-ray system intended to produce crosssectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac and vascular.

The Computed Tomography X-ray system, uCT 550, is intended to produce crosssectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast. The proposed device consists of CT scan gantry (including high voltage generator, X-ray tube, collimator and detectors), patient table, operating console (including console PC, monitor and Control Box), power supply cabinet (PSC), vital signal monitoring gated control unit (VSM), 3D camera, system software, and accessories.

uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular). uCT 780 is intended to 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. uWS-CT-Dual Energy Analysis 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 various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

The Computed Tomography X-ray System, uCT 780, is intended to produce cross-sectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast. The uWS-CT-Dual Energy Analysis 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 various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information. In this submission, the DETLA (Deep Recon) feature of the proposed device is modified and there is no other significant change compared with K230162.

The uDR 780i Digital Medical X-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography.

The uDR 780i is a digital radiography (DR) system that is designed to provide radiography examinations of sitting, standing or lying patients. It consists of the following components: Tube Ceiling Suspension with tube and collimator, Bucky Wall Stand, Elevating Table, High Voltage Generator, wireless flat panel detectors and an acquisition workstation. The system generates images which can be transferred through DICOM network for printing, review and storage.