{"product_name":"DeepTek CXR Analyzer","company_name":"DeepTek Medical Imaging","product_url":"https://www.deeptek.com/products/deeptek-cxr-analyzer","company_url":"https://www.deeptek.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0306","summary":"DeepTek CXR Analyzer is a US FDA-cleared AI solution that assists radiologists in detecting abnormalities in chest X-rays, covering the entire chest area and integrating seamlessly with existing PACS systems.","description":"DeepTek CXR Analyzer utilizes deep learning algorithms to identify, categorize, and highlight suspicious areas in chest X-rays, aiding clinicians in precise interpretations. It covers the entire chest area, including lung, pleura, and cardiac regions, and is compatible with various X-ray machines, including hospital-based, mobile, portable, hand-held, and ultra-portable units. The solution integrates seamlessly with existing PACS systems, operating in the background without disrupting current workflows. It has received US FDA clearance and CE MDR Class IIb certification, ensuring compliance with global medical device regulations.","categories":["diagnostic Support","clinical Care","radiology","imaging Software","Diagnostic","Clinical","Radiology","Ai-powered Imaging"],"market_segment":["enterprise","smb"],"target_users":["radiologists","clinicians","medical imaging professionals"],"specialties":["Pulmonology","Cardiology","Oncology","Infectious Diseases","Emergency Medicine","Pediatrics","Geriatrics","Orthopedics","Trauma Care","Intensive Care","Tuberculosis Screening","Pneumonia Detection","Chronic Obstructive Pulmonary Disease (copd)","Interstitial Lung Disease","Pulmonary Embolism","Lung Cancer","Pleural Effusion","Pneumothorax","Atelectasis","Fractures"],"regions_available":["United States","European Union","India","Singapore","Malaysia","Indonesia","Kenya","Thailand","Philippines","United Kingdom","Australia","New Zealand","Japan","South Korea","China","Brazil","Mexico","South Africa","Nigeria","Egypt"],"languages_supported":["English","Hindi","Malay","Indonesian","Swahili","Thai","Filipino","French","Portuguese","Spanish","Mandarin","Cantonese","Japanese","Korean","Arabic","Zulu","Yoruba","Igbo","Egyptian Arabic"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["India","United States","Singapore","Malaysia","Indonesia","Kenya","Thailand","Philippines","United Kingdom","Australia"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-powered analysis of chest X-rays","Detection of lung conditions (e.g., nodules, masses, tuberculosis, pneumothorax)","Identification of medical devices (e.g., chest leads, pacemakers, tubes)","Integration with existing PACS systems","Automated triaging and inference of scans","Color-coded bounding boxes highlighting suspicious regions","Backend operation without altering current workflows","Support for both on-premise and cloud deployments"],"optional_modules":["AI-assisted reporting service","AI-driven workflow optimization","Smart analytics dashboard","Smart communication command center with chatbox","Federated learning for data privacy","Split learning for data privacy","Edge device deployment","Population screening program support","TB screening solution","COVID-19 screening solution"],"integrations":["PACS systems","Blackford Platform","NTT DATA","NVIDIA","Docnet","Edison GE","Nobori"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","GDPR","ISO 27001","ISO 13485:2016","ISO 14971:2019","ISO/TR 24971:2020","IEC 62304:2006/Amd 1:2015","IEC 82304-1","IEC 62366-1:2015/Amd 1:2020","AAMI TIR57","IMDR 2017","EU MDR 2017/745","FDA 21 CFR Part 820","CDSCO MD-42","Thai FDA","Malaysia MDA","MoH Indonesia","Kenya Board","Singapore HSA","Philippines FDA","UK MHRA","Ayushman Bharat Health Account (ABHA) compliant"],"certifications":["FDA 510(k) clearance","CE Mark","ISO 13485:2016","ISO 27001:2022","ISO 14971:2019","ISO/TR 24971:2020","IEC 62304:2006/Amd 1:2015","IEC 82304-1","IEC 62366-1:2015/Amd 1:2020","AAMI TIR57","IMDR 2017","EU MDR 2017/745","FDA 21 CFR Part 820","CDSCO MD-42","Thai FDA","Malaysia MDA","MoH Indonesia","Kenya Board","Singapore HSA","Philippines FDA","UK MHRA","Ayushman Bharat Health Account (ABHA) compliant"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"Global hosting options","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0306","slug":"deeptek-cxr-analyzer","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/deeptek-cxr-analyzer.json"}}