{"product_name":"Prostate MR on syngo.via","company_name":"Siemens Healthineers","product_url":"https://www.siemens-healthineers.com/en-us/magnetic-resonance-imaging/clinical-specialities/prostate-mri","company_url":"https://www.siemens-healthineers.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0078","summary":"Prostate MR on syngo.via is an AI-powered software by Siemens Healthineers that assists in interpreting multiparametric prostate MRI scans, aiding in lesion detection, classification, and reporting.","description":"Prostate MR on syngo.via leverages deep neural networks to enhance the detection and classification of prostate lesions in MRI scans. It automates prostate gland segmentation, volumetric assessment, and generates pre-populated PI-RADS reports. The software integrates with syngo.via, Siemens Healthineers' advanced visualization and post-processing platform, and supports exporting results in RTSS format for MR/US fusion biopsies. It is CE certified as a Class IIa medical device but is not FDA approved and is not commercially available in some countries, including the U.S.","categories":["clinical Care","diagnostic Support","radiology","oncology Care","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","software Development","medical Device","healthcare It","pathology","Clinical","Diagnostic","Radiology","Oncology","Imaging","Artificial Intelligence","Software","Medical Device","Healthcare It","Biopsy Support"],"market_segment":["enterprise","smb"],"target_users":["radiologists","urologists","oncologists","medical imaging professionals","biopsy specialists"],"specialties":["Radiology","Oncology","Urology","Medical Imaging","Biopsy Procedures"],"regions_available":["Germany","Europe","Asia","Australia","Africa","Middle East","South America","North America (excluding U.S.)"],"languages_supported":["English","German","French","Spanish","Italian","Dutch","Portuguese","Russian","Chinese","Japanese","Korean","Arabic","Turkish","Hindi","Bengali","Punjabi","Vietnamese","Thai","Polish","Romanian"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Germany","United States","China","India","Japan","United Kingdom","France","Italy","Spain","Brazil"],"company_founding":"1847","deployment_model":["on_premise","cloud","hybrid"],"os_platforms":["Windows","Web"],"features":["Prostate gland segmentation and volumetric assessment","Lesion candidate localization and classification","Suspicion map highlighting lesion candidates","Pre-populated PI-RADS report","Exporting results in RTSS format","Automated prostate segmentation (T2/ADC)","Lesion detection and highlighting for PI-RADS assessment","Volumetric measurements of prostate and lesions","Automated calculation of prostate and lesion metrics","Supports MR-targeted biopsy planning / MR/US fusion export","Generation of structured DICOM-SR results","Integration into radiology reading workflow (syngo.via / viewer)","Confirmation workflow for reader review and editing","Visualization overlays and annotation tools","Exportable measurements for clinical/surgical use"],"optional_modules":["syngo.MR Spectro Engine","syngo.MR General Engine"],"integrations":["syngo.via","PACS (DICOM-compatible)","Ultrasound systems for MR/US fusion","Siemens MRI scanners and modalities","Radiology RIS / reporting systems","Hospital EHRs (via HL7/DICOM interfaces)"],"data_standards":["DICOM","DICOM Structured Reporting (DICOM-SR)","HL7 v2","IHE profiles"],"api_available":"unknown","system_requirements":"Windows workstation (syngo.via integration) or cloud access; DICOM network connectivity; internet access for cloud deployment","compliance":["HIPAA","GDPR"],"certifications":["FDA 510(k) (K193283)","CE (medical device)"],"security_features":["Data encryption in transit (TLS)","Role-based access control (RBAC)","Audit logging","SSO/SAML support"],"privacy_features":["Business Associate Agreement (BAA) available","Patient data anonymization/de-identification support"],"data_residency":"Supports on-premise installations; cloud deployments with regional hosting options (e.g., US/EU) or customer-hosted on-prem","customers":[],"user_reviews":[],"ratings":["4.5/5"],"support_channels":[],"training_options":[],"release_year":"\"\"","integration_partners":[],"id":"SW0078","slug":"prostate-mr-on-syngo-via","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/prostate-mr-on-syngo-via.json"}}