{"product_name":"Cardiac.Chambers.MR","company_name":"TeraRecon","product_url":"https://www.terarecon.com/advanced-visualization/mr-body","company_url":"https://www.terarecon.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0135","summary":"TeraRecon's Cardiac.Chambers.MR is an FDA-cleared software tool that automates the segmentation of cardiac chambers in MR scans, enhancing the efficiency and accuracy of cardiac assessments.","description":"Cardiac.Chambers.MR is a software application developed by TeraRecon, Inc., designed to automatically segment the anatomical structures of cardiac chambers from contrast or non-contrast cardiac MR scans in adult patients. It utilizes supervised deep learning-based algorithms to detect and segment the left and right ventricular myocardium and chambers from DICOM-compliant cardiovascular MR images acquired by various MR scanners. The device is intended to assist clinicians by providing precise delineation of the left and right ventricular walls, facilitating faster and more accurate cardiac assessment. The software is containerized and operates on Windows-based stand-alone workstations or servers accessible locally or remotely via thin clients or web viewers. It is not specific to any gender, ethnic group, or clinical condition. The device was FDA-cleared on November 5, 2024, under 510(k) number K241312. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K241312?utm_source=openai))","categories":["clinical Care","diagnostic Support","cardiology","imaging Software","software Development","ai Clinical Documentation Integrity","clinical Decision Support","medical Device","regulatory Compliance","customer Analytics","mri Imaging","Clinical","Diagnostic","Cardiology","Medical Imaging","Software","Artificial Intelligence","Medical Device","Fda-cleared","Segmentation","Cardiac Mr Imaging"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","Cardiologists","Medical Imaging Professionals"],"specialties":["Cardiology","Radiology","Medical Imaging"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States"],"company_founding":"1997","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Automatic segmentation of cardiac chambers' inner and outer walls of the left ventricle and inner wall of the right ventricle","Integration with DICOM-compliant MR imaging devices","Output of DICOM files compatible with other DICOM-compliant systems and image viewing systems like PACS","Intended to assist physicians in diagnosis or treatment planning"],"optional_modules":[],"integrations":["PACS","DICOM-compliant MR imaging devices"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA"],"privacy_features":["BAA available","consent management","anonymization","data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0135","slug":"cardiac-chambers-mr","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/cardiac-chambers-mr.json"}}