{"product_name":"SIGNA 7T MRI scanner","company_name":"GE HealthCare","product_url":"https://www.gehealthcare.com/products/magnetic-resonance-imaging/7t-mri-scanner","company_url":"https://www.gehealthcare.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0469","summary":"The SIGNA 7T MRI scanner by GE HealthCare is an ultra-high-field imaging system designed to enhance diagnostic confidence through superior contrast and signal-to-noise ratio (SNR) performance, utilizing advanced gradient technology and deep-learning applications.","description":"The SIGNA 7T MRI scanner is GE HealthCare's most powerful whole-body gradient platform, featuring a 7.0 Tesla magnet that delivers exceptional resolution and contrast-to-noise ratio. It is equipped with UltraG gradients, offering a peak amplitude of 113 mT/m and a peak slew rate of 260 T/m/s, enabling high-speed imaging and advanced applications. The system integrates a suite of SIGNA imaging applications and deep-learning tools, including AIR x™ Brain and Knee, as well as AIR™ Recon DL, facilitating both research and clinical use. Its design allows users to switch between clinical and research modes seamlessly, maintaining the same interface as other GE HealthCare MRI scanners for ease of use. The SIGNA 7T is FDA cleared and CE marked, though availability may vary by region.","categories":["diagnostic Support","clinical Care","clinical Research","neurology","imaging Software","mri Imaging","medical Device","healthcare Technology","Diagnostic","Clinical","Research","Neurology","Musculoskeletal","Imaging","Mri","Medical Device","Healthcare Technology","Medical Imaging"],"market_segment":["enterprise","research institutions","hospitals","medical centers","academic institutions"],"target_users":["radiologists","neurologists","musculoskeletal specialists","research scientists","medical imaging technicians","clinicians","physicians","medical researchers","healthcare providers","medical professionals"],"specialties":["Neurology","Musculoskeletal Imaging","Neuroimaging","Musculoskeletal Diseases","Neurological Disorders","Brain Imaging","Joint Imaging","Functional Brain Imaging","Diffusion Imaging","Quantitative Susceptibility Mapping","Stroke Imaging","Epilepsy","Parkinson's Disease","White Matter Diseases","Glioblastomas","Depression","Neurodegenerative Diseases","Traumatic Brain Injury","Alzheimer's Disease","Osteoarthritis"],"regions_available":["United States","European Union","India","United Kingdom","Canada","Australia","Japan","South Korea","China","Brazil","Mexico","South Africa","Russia","Middle East","Southeast Asia","Latin America","Africa","New Zealand","Caribbean","Central America"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Tamil","Telugu","Marathi","Gujarati","Malayalam"],"pricing_model":"enterprise_quote","pricing_details":"Contact GE HealthCare for pricing information.","license":"commercial","company_offices":["United States","United Kingdom","India","China","Japan","Germany","France","Italy","Brazil","Australia"],"company_founding":"1892","deployment_model":["on_prem"],"os_platforms":["Windows","Linux"],"features":["7.0T superconducting magnet","UltraG gradient technology with 113 mT/m amplitude and 260 T/m/s slew rate","SIGNAWorks software platform","AIR x™ Brain and Knee deep-learning tools","AIR™ Recon DL image reconstruction","Quantitative Susceptibility Mapping (QSM)","Advanced knee and cartilage imaging","Silent MR imaging","Precision RF transmit and receive architecture","Automated slice positioning"],"optional_modules":["Advanced diffusion imaging","Functional brain imaging","High-resolution tissue imaging","Neurodegenerative disease imaging","Musculoskeletal disease imaging","Quantitative imaging biomarkers","High-performance gradient imaging","Parallel transmit development","Research protocol deployment","Clinical protocol deployment"],"integrations":["PACS","DICOM","HL7","RIS","EMR","LIS","HIS","PACS workstations","3D visualization software","Post-processing software","Data storage solutions","Cloud storage services","Data analytics platforms","Clinical decision support systems","Patient monitoring systems","Radiology information systems","Hospital information systems","Laboratory information systems","Electronic medical records","Health information exchanges"],"data_standards":["DICOM","HL7","FHIR","ICD-10","SNOMED CT","LOINC","CPT","ICD-9","NDC","HCPCS"],"api_available":"yes","system_requirements":"Windows Server 2016 or later, Linux CentOS 7 or later, 64 GB RAM, 1 TB SSD storage, 1 Gbps network connection","compliance":["HIPAA","FDA 510(k)","CE Mark","ISO 13485","ISO 14971","IEC 60601-1","IEC 60601-2-33","IEC 60601-2-44","IEC 60601-2-52","IEC 60601-2-57","IEC 60601-2-58","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"],"certifications":["FDA 510(k)","CE Mark","ISO 13485","ISO 14971","IEC 60601-1","IEC 60601-2-33","IEC 60601-2-44","IEC 60601-2-52","IEC 60601-2-57","IEC 60601-2-58","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","ISO 9001","ISO 14001","ISO 27001","ISO 45001"],"security_features":["Encryption","Role-Based Access Control (RBAC)","Single Sign-On (SSO)","Audit logs","Two-Factor Authentication (2FA)","Data Loss Prevention (DLP)","Network segmentation","Firewalls","Intrusion Detection Systems (IDS)","Intrusion Prevention Systems (IPS)"],"privacy_features":["Business Associate Agreement (BAA)","Consent management","Anonymization","Data minimization","Data masking","Access controls","Data retention policies","Data destruction policies","Data encryption","Data segregation"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0469","slug":"signa-7t-mri-scanner","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/signa-7t-mri-scanner.json"}}