{"product_name":"MPXA-2000","company_name":"Medipixel","product_url":"https://medipixel.com","company_url":"https://medipixel.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0372","summary":"MPXA-2000 is an AI-driven software developed by Medipixel to assist cardiologists and radiologists in analyzing coronary angiographic X-ray images, providing real-time, automated vessel segmentation and lesion quantification to support clinical decision-making.","description":"MPXA-2000 is a software tool intended for cardiologists and radiologists to automatically analyze X-ray angiographic images of the coronary arteries. It uses deep learning and computer vision algorithms to segment blood vessels, classify vessel types, quantify vessel dimensions, and support clinical decisions related to coronary artery disease. The software provides validated, reproducible quantitative results to aid in diagnosis and treatment evaluation, with results available for review and export. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K222036?utm_source=openai))","categories":["clinical Care","diagnostic Support","cardiology","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","Clinical","Diagnostic","Cardiology","Medical Imaging","Artificial Intelligence"],"market_segment":["Enterprise","SMB"],"target_users":["Cardiologists","Radiologists","Medical Imaging Professionals"],"specialties":["Cardiology","Radiology"],"regions_available":["United States","South Korea"],"languages_supported":["English","Korean"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["South Korea","United States"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Automated analysis of coronary X-ray angiographic images","Deep learning-based vessel segmentation and classification","Quantification of vessel dimensions","Support for clinical decisions in coronary artery disease","Validated and reproducible quantitative results","Results available for review and export"],"optional_modules":["Frame selection","Vessel segmentation","Vessel classification","ROI quantification","Result visualization/export"],"integrations":["DICOM X-ray angiographic images from various vendors"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["FDA 510(k) clearance","IEC 62304 software lifecycle processes","ISO 13485 certification","MDSAP certification","GMP certification","HIPAA compliance","GDPR compliance","HITECH compliance","SOC 2 compliance","ISO 27001 compliance"],"certifications":["FDA 510(k) clearance","ISO 13485 certification","MDSAP certification","GMP certification","HIPAA compliance","GDPR compliance","HITECH compliance","SOC 2 compliance","ISO 27001 compliance"],"security_features":["Encryption","RBAC","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":"SW0372","slug":"mpxa-2000","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/mpxa-2000.json"}}