{"product_name":"NvisionVLE Imaging System","company_name":"Intelligent Retinal Imaging Systems","product_url":"https://www.intelligentretinal.com","company_url":"https://www.intelligentretinal.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0002","summary":"The NvisionVLE Imaging System is an optical coherence tomography (OCT) device that provides real-time, high-resolution cross-sectional images of tissue microstructures, aiding in the detection of diseases not visible with conventional imaging methods.","description":"The NvisionVLE Imaging System utilizes optical coherence tomography (OCT) technology to produce real-time, high-resolution cross-sectional images of tissue microstructures. It is designed to assist clinicians in evaluating tissue surfaces and subsurfaces for potential diseases that may not be detectable with traditional imaging techniques such as endoscopy and ultrasound. The system has received FDA clearance for imaging esophageal tissue and has been expanded to include applications for the pancreas and bile duct. Additionally, the system features the Intelligent Real-time Image Segmentation (IRIS) software, an AI-based platform that enhances image feature segmentation, marking the first of its kind approved for imaging esophageal tissue. This advancement aims to improve biopsy targeting and treatment planning by providing more complete information to clinicians during endoscopic procedures.","categories":["diagnostic Support","clinical Care","administrative Operations","Diagnostic","Clinical","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","gastroenterologists","pathologists"],"specialties":["Gastroenterology","Oncology","Radiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States"],"company_founding":"2009","deployment_model":["on_prem"],"os_platforms":["Windows","macOS","Linux"],"features":["Real-time high-resolution cross-sectional imaging","Volumetric Laser Endomicroscopy (VLE)","Optical Coherence Tomography (OCT) technology","Real-time Targeting feature for tissue marking","Artificial Intelligence-based image segmentation (IRIS)","Enhanced biopsy targeting","Evaluation of esophageal tissue microstructure","Cross-sectional and longitudinal imaging views","High-speed optical probe with balloon catheter","User-friendly touch-screen monitor interface","Hand-controller for real-time scan control","Single and double mark options for tissue marking","Compatibility with endoscope channels 2.8mm or larger","Advanced image processing algorithms","Real-time visualization of tissue features","Improved diagnostic confidence","Streamlined endoscopic procedures","High-resolution imaging up to 3mm depth","Enhanced workflow for clinicians"],"optional_modules":["IRIS software upgrade for AI-based image segmentation"],"integrations":["Endoscope systems","Medical imaging devices"],"data_standards":["DICOM"],"api_available":"no","system_requirements":"Windows, macOS, Linux","compliance":["FDA 510(k) clearance","CE Mark approval","ISO 13485:2003 certification"],"certifications":["FDA 510(k) clearance","CE Mark approval","ISO 13485:2003 certification"],"security_features":["Data encryption","User authentication","Audit logs"],"privacy_features":["Data anonymization","Consent management"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0002","slug":"nvisionvle-imaging-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/nvisionvle-imaging-system.json"}}