{"product_name":"Discovery MI Gen 2","company_name":"GE HealthCare","product_url":"https://www.gehealthcare.com/products/molecular-imaging/pet-ct/discovery-mi-gen-2","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":"SW0454","summary":"Discovery MI Gen 2 is GE HealthCare's advanced digital PET/CT system, offering enhanced sensitivity and imaging capabilities for precise diagnostics.","description":"Discovery MI Gen 2 is GE HealthCare's next-generation digital PET/CT system, designed to provide high-resolution imaging with exceptional sensitivity. It features a scalable field of view (FOV) from 15 cm to 30 cm, enabling comprehensive whole-body imaging. The system incorporates advanced digital detectors, including the LightBurst Digital Detector, which combines small lutetium-based scintillator crystals with Silicon Photomultiplier (SiPM) technology to improve sensitivity, scan times, and required dose levels. Additionally, it offers Q.Clear for up to a twofold improvement in image quality (SNR) and MotionFree for up to a 67% improvement in lesion volume measurements. The system also includes TrueFidelity, a deep-learning-based image reconstruction technology, and AutoIN, which allows technologists to define landmarks and position the patient table from the control console, enhancing workflow efficiency. Discovery MI Gen 2 is designed to detect smaller lesions, achieve a 125% increase in sensitivity, and provide up to a 41% improvement in small lesion detectability. It also reduces scan times by up to 50% and decreases injected dose by up to 50%. The system is CE marked and 510(k) pending with the FDA, not yet available for sale in the U.S. as of October 2025.","categories":["imaging Software","medical Device","imaging Equipment","radiology","Clinical Imaging","Diagnostic Imaging","Molecular Imaging","Pet/ct Imaging","Medical Devices","Medical Imaging Equipment","Radiology","Oncology Imaging","Cardiology Imaging","Neurology Imaging"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","Medical Technologists","Oncologists","Cardiologists","Neurologists"],"specialties":["Oncology","Cardiology","Neurology","Radiology","Nuclear Medicine","Internal Medicine","Emergency Medicine","Orthopedics","Pediatrics","Geriatrics","Pulmonology","Endocrinology","Gastroenterology","Hematology","Infectious Disease","Rheumatology","Urology","Obstetrics And Gynecology","Ophthalmology","Dermatology"],"regions_available":["United States","Canada","Mexico","Brazil","Argentina","United Kingdom","Germany","France","Italy","Spain","Turkey","Middle East","India","China","Japan","South Korea","Australia","New Zealand","South Africa","Egypt"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Turkish","Arabic","Chinese","Japanese","Korean","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Gujarati","Malayalam","Kannada","Odia","Assamese"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","United Kingdom","Germany","France","Italy","Spain","Turkey","Middle East","India","China","Japan","South Korea","Australia","New Zealand","South Africa","Egypt","Brazil","Argentina","Mexico","Canada"],"company_founding":"1892","deployment_model":["on_prem","hybrid"],"os_platforms":["Windows","Linux"],"features":["Digital detectors with scalable field of view up to 30 cm","High sensitivity per cm (cps/kBq/cm)","Motion correction with MotionFree technology","Q.Clear for improved PET quantification accuracy","Whole-body Dynamic IQ Protocol for dynamic acquisitions","Deep-learning based image reconstruction with Revolution EVO Gen 3 CT","Smart MAR for reduction of metal artifacts","Diagnostic CT imaging capabilities","Enhanced image quality with up to 2x improvement in SNR","Up to 2x improvement in quantitative SUV (SUVmean)"],"optional_modules":["MotionFree","Revolution EVO Gen 3 CT","Smart MAR","Q.Clear","Whole-body Dynamic IQ Protocol"],"integrations":["Revolution EVO Gen 3 CT","MotionFree","Smart MAR","Q.Clear","Whole-body Dynamic IQ Protocol"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"Windows Server 2016 or later, Linux CentOS 7 or later, Intel Xeon processor, 16 GB RAM, 1 TB HDD","compliance":["HIPAA","FDA 510(k)","IEC 60601-1 Ed. 3","21 CFR Subchapter J","NEMA standards"],"certifications":["FDA 510(k)","CE Mark","IEC 60601-1 Ed. 3","21 CFR Subchapter J","NEMA standards"],"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":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0454","slug":"discovery-mi-gen-2","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/discovery-mi-gen-2.json"}}