{"product_name":"breastscape","company_name":"Olea Medical","product_url":"https://www.olea-medical.com/en/solutions/womens-health/","company_url":"https://www.olea-medical.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0456","summary":"Breastscape is an advanced MRI post-processing software by Olea Medical, designed to enhance breast imaging interpretation and patient management.","description":"Breastscape is a medical imaging post-processing software developed by Olea Medical, intended for use by trained breast imaging physicians and MRI technologists. It operates as an optional application on the Olea Sphere V3.0 software package, facilitating visualization, analysis, and reporting of breast MRI lesions, dynamic contrast evaluation, lesion measurements, and MR-guided breast intervention planning. The software comprises two modules: BreastApp, which supports visualization, analysis, and reporting of lesion measurements, and BreastLoc, which assists in planning MR-guided breast interventional procedures. Data and images are acquired through DICOM-compliant imaging devices and modalities. Breastscape is a Class IIa medical device, manufactured and marketed by Olea Medical SAS (France), and is not reimbursed by insurance organizations. It is designed and produced according to the EN ISO 13485 Quality management system. Instructions for use are available on the Olea Medical website. ([olea-medical.com](https://www.olea-medical.com/en/legal-mentions/?utm_source=openai))","categories":["clinical Care","imaging Software","mri Imaging","medical Device","healthcare It","radiology","healthcare Technology","Clinical","Diagnostic Imaging","Medical Imaging Software","Breast Imaging","Mri Post-processing","Medical Device","Healthcare It","Radiology","Women's Health","Medical Technology"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","MRI Technologists","Medical Imaging Professionals","Healthcare Providers"],"specialties":["Radiology","Breast Imaging","Medical Imaging","Women's Health","Oncology","Medical Technology","Healthcare It","Mri Imaging","Medical Devices","Clinical Decision Support"],"regions_available":["France","United States","Europe","North America","Asia","Africa","South America","Australia","New Zealand","Global"],"languages_supported":["English","French","Spanish","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Javanese","Turkish","Vietnamese","Telugu","Marathi"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["France","United States","Germany","United Kingdom","Italy","Spain","Netherlands","Belgium","Switzerland","Canada"],"company_founding":"2010","deployment_model":["on_prem","hybrid"],"os_platforms":["Windows","Linux"],"features":["Lesion segmentation and volumetry","DCE and ADC quantification","Lesion follow-up","BI-RADS report integration","ACR classification","Guidance for breast biopsy procedures","Motion correction for improved analysis","Automated and standardized reporting","Longitudinal analysis of multiple examinations","4D MIP, MPR, and 3D rendering of volumes of interest","Integrated BI-RADS lexicon from ACR","Assistance in biopsy planning","Automatic computation of parametric maps","Secure access from any workstation","No specific on-premises hardware required","Scalable virtual application tailored to radiologists' requirements","Automatic subtractions","Automatic computation of volumes and distances","Analysis of morphologic and functional series (DWI, DCE)"],"optional_modules":["BreastApp","BreastLoc"],"integrations":["PACS","DICOM-compliant imaging devices"],"data_standards":["DICOM","PDF","DICOM-PDF","DICOM (imaging)"],"api_available":"unknown","system_requirements":"Windows or Linux OS, DICOM-compliant imaging devices","compliance":["CE Certified, Class IIa, MDD","FDA 510(k) Cleared, Class II"],"certifications":["CE Certified, Class IIa, MDD","FDA 510(k) Cleared, Class II"],"security_features":["Secure data transfer through VPN","Secure access from any workstation"],"privacy_features":["No specific on-premises hardware required","Scalable virtual application tailored to radiologists' requirements"],"data_residency":"On-premises deployment","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0456","slug":"breastscape","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/breastscape.json"}}