{"product_name":"CoLumboX","company_name":"Smart Soft Healthcare","product_url":"https://columbo.me/","company_url":"https://columbo.me/","related_urls":["https://radiology.healthairegister.com/products/smart-soft-columbo/","https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241211.pdf","https://healthairegister.com/products/smart-soft-columbo","https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0010","summary":"CoLumboX is an AI-powered software developed by Smart Soft Healthcare to assist radiologists in analyzing lumbar spine MRI scans, enhancing efficiency and accuracy in reporting.","description":"CoLumboX utilizes deep learning algorithms to automatically segment and measure lumbar spine features from MRI images, providing quantitative assessments and generating draft reports for radiologists. It supports the detection of various spinal conditions, including disk herniation, central spinal stenosis, and scoliosis. The software has received FDA 510(k) clearance and CE Mark certification, indicating its safety and effectiveness for clinical use in the U.S. and Europe. CoLumboX is designed to integrate seamlessly into existing radiology workflows, aiming to reduce reading and reporting time by up to 25% and decrease errors of omission by up to 15%. It is available in multiple languages and is marketed in several countries, including the USA, Germany, Italy, France, Spain, Belgium, Netherlands, Austria, and Switzerland. The company offers a pay-per-use and subscription-based pricing model, with costs based on the number of analyses performed. CoLumboX is licensed under commercial terms, and Smart Soft Healthcare has offices in Bulgaria and other countries. The company was founded in 2018.","categories":["clinical Care","diagnostic Support","radiology","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","software Development","medical Device","regulatory Compliance","mri Imaging","Clinical","Diagnostic","Radiology","Medical Imaging","Artificial Intelligence","Software","Medical Device","Fda Cleared","Ce Marked","Lumbar Spine Mri"],"market_segment":["enterprise","smb"],"target_users":["radiologists","spine surgeons","medical imaging centers","hospitals","healthcare professionals"],"specialties":["Radiology","Orthopedics","Neurology","Spine Surgery","Musculoskeletal Imaging","Medical Imaging","Artificial Intelligence","Healthcare Software","Medical Devices","Fda Cleared","Ce Marked","Lumbar Spine Mri"],"regions_available":["USA","Germany","Italy","France","Spain","Belgium","Netherlands","Austria","Switzerland"],"languages_supported":["English","German","Italian","French","Spanish","Dutch","Bulgarian"],"pricing_model":"subscription","pricing_details":"Pay-per-use and subscription-based pricing models, with costs based on the number of analyses performed. Contact vendor for detailed pricing information.","license":"commercial","company_offices":["Bulgaria","USA","Germany","Italy","France","Spain","Belgium","Netherlands","Austria","Switzerland"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated lumbar spine MRI segmentation","Automated measurements (distances, areas, angles)","Pre-populated draft radiology report generation","Pathology detection and localization (herniation, stenosis, etc.)","Customizable pathology thresholds and severity levels","Multi-language report output","Visual overlays and measurement markup on images","Standardization of reporting across sites","Batch processing for throughput improvements","Performance metrics to reduce reporting time and omissions"],"optional_modules":["Advanced MRI features","Postoperative patient optimization without contrast media"],"integrations":["PACS (DICOM-compatible)","RIS","EMR","Nuance (Precision Imaging Network / AI Services Catalog)","Blackford Analysis","Philips Healthcare","Sectra","Incepto","Deepc","Ferrum Health"],"data_standards":["DICOM","HL7 v2","FHIR","IHE","SNOMED CT","ICD-10"],"api_available":"yes","system_requirements":"DICOM-compatible PACS, RIS, EMR systems","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001","ISO 13485","FDA 510(k)","CE mark (MDR, Class IIa)","TGA ARTG listing"],"certifications":["FDA 510(k)","CE mark (MDR, Class IIa)","TGA ARTG listing","ISO 13485","ISO 27001"],"security_features":["Encryption at rest (AES-256)","Encryption in transit (TLS 1.3)","Access control (RBAC + MFA)","Audit logging (100% coverage)","Data retention (7 years)"],"privacy_features":["Business Associate Agreement (BAA) available","Consent management","Anonymization","Data minimization"],"data_residency":"EU-only, US/EU regions, BYO cloud region","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0010","slug":"columbox","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/columbox.json"}}