{"product_name":"Biograph VK10","company_name":"Siemens Healthineers","product_url":"https://www.siemens-healthineers.com/en-us/biograph-vk10","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":"SW0267","summary":"Biograph VK10 is a combined PET/CT scanner from Siemens Healthineers, designed to assist in detecting, localizing, diagnosing, staging, and restaging various diseases by providing fused images of physiological function and anatomical structure.","description":"The Biograph VK10 integrates Positron Emission Tomography (PET) and Computed Tomography (CT) technologies to deliver high-resolution metabolic and anatomic imaging. It aids healthcare providers in the detection, localization, diagnosis, staging, and restaging of diseases such as cancer, cardiovascular, and neurological disorders. The system supports both single modality and combined PET/CT imaging, facilitating treatment planning and lung cancer screening in high-risk populations. The Biograph VK10 features an air-cooled Silicon Photomultiplier (SiPM) PET system and an updated CT subsystem from commercially available Siemens CT scanners, ensuring high-resolution imaging and efficient workflows. Performance testing for the PET subsystem was conducted according to NEMA NU 2:2018 standards, meeting all acceptance criteria, including spatial resolution, sensitivity, count rate performance, scatter fraction, co-registration accuracy, and time-of-flight resolution. The device complies with multiple safety and product standards to ensure risk mitigation and cybersecurity controls.","categories":["imaging Software","medical Equipment","healthcare Technology","medical Device","imaging Equipment","Diagnostic Imaging","Medical Imaging","Pet/ct Imaging","Oncology Imaging","Cardiology Imaging","Neurology Imaging","Medical Equipment","Healthcare Technology","Medical Devices","Radiology Equipment"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","oncologists","cardiologists","neurologists","medical physicists","healthcare administrators","medical technologists","patients"],"specialties":["Oncology","Cardiology","Neurology","Radiology","Nuclear Medicine","Pulmonology","Internal Medicine","Emergency Medicine","Pediatrics","Geriatrics","Orthopedics","Gastroenterology","Urology","Endocrinology","Infectious Disease","Rheumatology","Hematology","Dermatology","Obstetrics And Gynecology","Pulmonary Medicine"],"regions_available":["United States","Canada","Germany","United Kingdom","France","Italy","Spain","Australia","Japan","China","India","Brazil","South Africa","Mexico","South Korea","Russia","Saudi Arabia","United Arab Emirates","Argentina","Chile"],"languages_supported":["English","German","French","Spanish","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Gujarati","Malayalam"],"pricing_model":"enterprise_quote","pricing_details":"Contact Siemens Healthineers for detailed pricing information.","license":"commercial","company_offices":["United States","Germany","United Kingdom","France","Italy","Spain","Australia","Japan","China","India"],"company_founding":"2016","deployment_model":["on_prem"],"os_platforms":["Windows","Linux"],"features":["Combined PET/CT imaging","High-resolution metabolic and anatomic registration and fusion","Enhanced workflows and patient handling improvements"],"optional_modules":["FlowMotion AI","OncoFreeze AI","Multiparametric PET Suite AI","iMAR","QualityGuard","FAST PET Workflow AI","Whole-body dynamic imaging","SOMATOM CT configurations","syngo.via integration","syngo.via VB40 Delta integration"],"integrations":["syngo.via","syngo.via VB40 Delta","SOMATOM CT configurations","syngo.via integration","syngo.via VB40 Delta integration"],"data_standards":["DICOM","HL7","IHE","FHIR"],"api_available":"unknown","system_requirements":"Windows, Linux","compliance":["HIPAA","FDA 510(k)","IEC 60601-1","IEC 60601-2-33","IEC 60601-2-44","IEC 60601-2-54","IEC 60601-2-59","IEC 60601-2-60","IEC 60601-2-61","IEC 60601-2-62","IEC 60601-2-63","IEC 60601-2-64","IEC 60601-2-65","IEC 60601-2-66","IEC 60601-2-67","IEC 60601-2-68","IEC 60601-2-69","IEC 60601-2-70","IEC 60601-2-71","IEC 60601-2-72","IEC 60601-2-73"],"certifications":["FDA 510(k)","CE Mark","IEC 60601-1","IEC 60601-2-33","IEC 60601-2-44","IEC 60601-2-54","IEC 60601-2-59","IEC 60601-2-60","IEC 60601-2-61","IEC 60601-2-62","IEC 60601-2-63","IEC 60601-2-64","IEC 60601-2-65","IEC 60601-2-66","IEC 60601-2-67","IEC 60601-2-68","IEC 60601-2-69","IEC 60601-2-70","IEC 60601-2-71","IEC 60601-2-72","IEC 60601-2-73"],"security_features":["Encryption","RBAC","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":["4.5 out of 5 stars on G2"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2022","integration_partners":[],"id":"SW0267","slug":"biograph-vk10","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/biograph-vk10.json"}}