{"product_name":"Preview Shoulder","company_name":"Genesis Software Innovations","product_url":"https://genesissoftware.com/preview-shoulder","company_url":"https://genesissoftware.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0235","summary":"PreView Shoulder is a 3D pre-operative planning software developed by Genesis Software Innovations, designed to assist orthopedic surgeons in planning shoulder arthroplasty procedures using CT imaging data.","description":"PreView Shoulder enables surgeons to visualize a patient's shoulder anatomy in 3D, facilitating the digital placement of implants to optimize size, location, and orientation. This tool aims to improve surgical efficiency, reduce operating room time, and enhance patient outcomes. It received FDA 510(k) clearance in May 2021, marking it as the first orthopedic solution under the FDA's new QIH classification for AI-based software solutions. The software was developed by an international team of shoulder reconstruction specialists, AI engineers, and visual gaming programmers. In May 2021, Shoulder Innovations signed an exclusive license agreement for PreView Shoulder, integrating it into their shoulder replacement portfolio to provide greater surgical clarity. The software is available for use in the United States and is supported in English. Pricing details are not publicly disclosed; interested parties are advised to contact Genesis Software Innovations directly for more information. The company was founded in 2018 and is headquartered in Grand Rapids, Michigan, USA.","categories":["clinical Care","diagnostic Support","surgical Planning","Clinical","Diagnostic","Surgical Planning"],"market_segment":["enterprise","smb"],"target_users":["orthopedic surgeons","medical professionals"],"specialties":["Orthopedics","Shoulder Surgery"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"contact vendor","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Reconciliation component","Straight-through data integration","Local development performance","Accessibility compliance","Updates to Genesis Create","Improved Angular support"],"optional_modules":["Matcher solution","Reconciliation component","Genesis Create","Genesis View","Angular support enhancements"],"integrations":["ERP systems","EHR systems","Finance systems","P2P systems","Catalogue systems"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"yes","system_requirements":["AWS","Azure","Google Cloud","Docker"],"compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 9001","ISO 27017","ISO 27018","SOC 1","SOC 2","SOC 3","PCI DSS Level 1","FedRAMP","FIPS","IRAP","MLPS Level 3","MTCS Tier 3","SEC Rule 17a-4(f)","C5","Cyber Essentials Plus","DoD SRG","FISMA","G-Cloud","GxP (FDA CFR 21 Part 11)","IT Grundschutz","MITA 3.0","MPAA","NIST","PHR","UK Cloud Security Principles","Uptime Institute Tiers"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0235","slug":"preview-shoulder","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/preview-shoulder.json"}}