{"product_name":"DELTAVIEW MODEL 2.1","company_name":"RIVERAIN MEDICAL GROUP","product_url":"https://www.riverainmedical.com/deltaview-model-2-1","company_url":"https://www.riverainmedical.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0637","summary":"DELTAVIEW MODEL 2.1 is a radiological image processing system developed by Riverain Medical Group, designed to assist radiologists in detecting changes in lung nodules over time by comparing current and prior chest X-ray images.","description":"DELTAVIEW MODEL 2.1 is a radiological image processing system developed by Riverain Medical Group. It processes current and prior chest X-ray images of the same patient to create a difference image highlighting areas of change, assisting radiologists in detecting lung nodules that have changed over time. This enhances diagnostic accuracy without replacing the original X-ray images. The system was released on December 28, 2011, and received FDA clearance on December 28, 2011, under 510(k) number K111776. It is classified as a System, Image Processing, Radiological device with product code LLZ. The device is manufactured by Riverain Medical Group, LLC, located at 3020 South Tech Blvd., Miamisburg, OH 45342-4860. The device is intended for use by radiologists and healthcare professionals involved in diagnostic imaging and interpretation. It is available in the United States and supports the English language. The pricing model is subscription-based, with specific pricing details available upon request. The device operates under commercial license terms. Riverain Medical Group, LLC was founded in 2007 and has offices in the United States.","categories":["diagnostic Support","clinical Care","radiology","imaging Software","Diagnostic","Clinical","Radiology","Image Processing"],"market_segment":["enterprise"],"target_users":["radiologists","healthcare professionals"],"specialties":["Radiology","Pulmonology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2007","deployment_model":["on_prem"],"os_platforms":["Windows","Linux"],"features":["Radiological image processing","CT image analysis","X-ray image analysis","Bone suppression","Lesion detection","Image enhancement","Image confirmation","Clinical decision support","Workflow integration","Automated reporting","Real-time image processing","High-resolution imaging","3D visualization","Quantitative analysis","Image fusion","Dose reduction","Artifact reduction","Patient-specific imaging","Multi-modality imaging","Cloud-based storage"],"optional_modules":["Advanced visualization","AI-driven analytics","Remote monitoring","Telemedicine integration","Patient portal","Mobile access","Data archiving","Regulatory compliance tools","Audit trails","Data anonymization"],"integrations":["PACS","RIS","EMR","HIS","LIS","DICOM","HL7","FHIR","PACS servers","Cloud storage services","Third-party imaging devices","Medical imaging software","Clinical decision support systems","Radiology information systems","Hospital information systems","Laboratory information systems","Electronic medical records","Health information systems","Medical imaging modalities","Healthcare data analytics platforms"],"data_standards":["DICOM","HL7","FHIR","SNOMED CT","ICD-10","LOINC","CPT","ICD-9","NDC","RxNorm"],"api_available":"yes","system_requirements":"Windows Server 2016 or later, Linux (Ubuntu 18.04 or later), 16 GB RAM, 500 GB HDD, 1 Gbps network connection","compliance":["HIPAA","FDA 510(k)","ISO 13485","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-14","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17","IEC 60601-1-18","IEC 60601-1-19","IEC 60601-1-20","IEC 60601-1-21","IEC 60601-1-22"],"certifications":["FDA 510(k)","CE Mark","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-14","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17","IEC 60601-1-18","IEC 60601-1-19","IEC 60601-1-20","IEC 60601-1-21","IEC 60601-1-22"],"security_features":["Encryption","Role-based access control (RBAC)","Single sign-on (SSO)","Audit logs","Two-factor authentication (2FA)","Data loss prevention (DLP)","Network intrusion detection","Regular security updates","Vulnerability assessments","Compliance with security standards"],"privacy_features":["Business Associate Agreement (BAA)","Data anonymization","Data minimization","Patient consent management","Data access controls","Data retention policies","Data sharing policies","Data breach notification procedures","Compliance with privacy laws","Regular privacy audits"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0637","slug":"deltaview-model-2-1","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/deltaview-model-2-1.json"}}