{"product_name":"uOmnispace","company_name":"United Imaging","product_url":"https://www.united-imaging.com/products/uomnispace","company_url":"https://www.united-imaging.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0276","summary":"uOmnispace is an advanced software platform developed by United Imaging for viewing, processing, and analyzing medical images from PET, CT, MR, and SPECT scans, supporting clinical workflows in oncology, neurology, and cardiology.","description":"uOmnispace is a hospital-grade intelligent post-processing software suite designed to assist healthcare professionals in viewing, processing, evaluating, and analyzing medical images from various modalities, including PET, CT, MR, and SPECT scans. It offers tools for image registration, lesion segmentation, and quantitative analysis, supporting clinical workflows in oncology, neurology, and cardiology. The software integrates multiple applications, such as fusion imaging, dynamic analysis, brain scan quantification, and cardiac function analysis, to aid clinicians in making timely and accurate diagnoses. uOmnispace utilizes deep learning-based algorithms for spine and rib labeling, with performance validation conducted on large, diverse datasets to ensure high accuracy and robustness across subgroups. The software is intended for use within healthcare institutions and is classified under the FDA product code LLZ for radiology devices. It received FDA clearance on December 20, 2023, under 510(k) number K233176. The software is developed by Shanghai United Imaging Healthcare Co., Ltd., a global leader in advanced medical imaging and radiotherapy equipment, founded in 2011, with subsidiaries and R&D centers across the world. The company has its North American headquarters in Houston, Texas, which includes corporate offices, a factory, product showroom, service training center, and service parts distribution center. United Imaging's mission is Equal Healthcare for All™, guiding its innovation standards and global culture. The uOmnispace software is part of United Imaging's comprehensive portfolio of medical imaging solutions, which also includes MRI, CT, and PET/CT systems, as well as AI-powered applications for various imaging modalities. The company emphasizes vertical integration in manufacturing to ensure speed, quality, and cost controls, benefiting healthcare providers. United Imaging continues to advance medical innovation through exceptional R&D capabilities and industry leadership, with a commitment to providing equal healthcare for all patients.","categories":["clinical Care","diagnostic Support","oncology Care","neurology","cardiology","radiology","software Development","ai Clinical Documentation Integrity","imaging Software","Clinical","Diagnostic","Oncology","Neurology","Cardiology","Radiology","Software","Ai-powered","Image Processing","Medical Imaging"],"market_segment":["enterprise","healthcare institutions","medical imaging centers","hospitals","clinics"],"target_users":["radiologists","oncologists","neurologists","cardiologists","medical imaging technologists","healthcare professionals"],"specialties":["Oncology","Neurology","Cardiology","Radiology","Medical Imaging"],"regions_available":["United States","China","Europe","Asia","Africa","Australia","South America","North America","Middle East","Southeast Asia"],"languages_supported":["English","Chinese","Spanish","French","German","Italian","Portuguese","Russian","Japanese","Korean"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States","China","Germany","France","Italy","Japan","South Korea","India","Brazil","Mexico"],"company_founding":"2011","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Image registration","Lesion segmentation","Quantitative analysis","Fusion imaging","Dynamic PET data analysis","Brain scan quantification","Cardiac function analysis","Spine and rib labeling using deep learning algorithms"],"optional_modules":["uAI Vision 3D camera","AI-powered reconstruction","Smart quality control","Research toolkit"],"integrations":["Epic","Cerner","PACS","Billing systems","Nuance PowerScribe 360 API"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":["Windows Server 2016 or later","Linux (CentOS 7 or later)","Minimum 16 GB RAM","Minimum 100 GB free disk space"],"compliance":["HIPAA","HITECH","GDPR","SOC 2","ISO 27001"],"certifications":["FDA 510(k) clearance","CE Marking","ONC Health IT Certification","ISO 13485","ISO 9001"],"security_features":["End-to-end encryption","Role-based access control (RBAC)","Single sign-on (SSO)","Audit logs","Two-factor authentication (2FA)","Data loss prevention (DLP)"],"privacy_features":["Business Associate Agreement (BAA)","Consent management","Data anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0276","slug":"uomnispace","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/uomnispace.json"}}