JSON twin: https://www.healthaidb.com/software/columbo.json
Smart Soft Healthcare
AI assistant that automatically segments, measures and generates draft reports for lumbar spine MRI to help radiologists detect and quantify spinal pathologies.
CoLumbo (Smart Soft Healthcare) is an AI/deep‑learning software for automated analysis of lumbar spine MRI. It performs pixel‑level segmentation, detects and measures discs, herniations, vertebral bodies, stenosis and angles, provides graded findings and editable draft radiology reports, and delivers DICOM/DICOM‑PDF outputs. Deployable cloud or locally, it integrates with PACS and several AI marketplaces and is CE marked (MDR, Class IIa) and FDA 510(k) cleared (Class II).
yes
2021
P2010
2025-09-07
commercial, proprietary
subscription priced by number of analyses; contact vendor for tiers and quotation
subscription
2021
DICOM-compatible PACS; Windows/Linux server for on-prem; GPU recommended for inference; or cloud-hosted SaaS access
product
1.0
{
"company_name": "Smart Soft Healthcare",
"company_url": "https://columbo.me/",
"company_offices": [
"Bulgaria"
],
"company_founding": "2021",
"product_url": "https://columbo.me/",
"categories": [
"clinical",
"diagnostic",
"imaging",
"radiology",
"AI / machine learning",
"workflow integration"
],
"market_segment": [
"enterprise",
"smb"
],
"links": [
"https://columbo.me/",
"https://columbo.me/about-us/",
"https://columbo.me/docs-category/questions/",
"https://columbo.me/wp-content/uploads/2025/06/FDA-CoLumbo-v3-K241211.pdf",
"https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241211.pdf",
"https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220497.pdf",
"https://healthairegister.com/products/smart-soft-columbo",
"https://incepto-medical.com/product/columbo",
"https://amplifiermarketplace.sectra.com/application/columbo-us/",
"https://blackfordanalysis.com/ai-portfolio-columbo"
],
"summary": "AI assistant that automatically segments, measures and generates draft reports for lumbar spine MRI to help radiologists detect and quantify spinal pathologies.",
"description": "CoLumbo (Smart Soft Healthcare) is an AI/deep‑learning software for automated analysis of lumbar spine MRI. It performs pixel‑level segmentation, detects and measures discs, herniations, vertebral bodies, stenosis and angles, provides graded findings and editable draft radiology reports, and delivers DICOM/DICOM‑PDF outputs. Deployable cloud or locally, it integrates with PACS and several AI marketplaces and is CE marked (MDR, Class IIa) and FDA 510(k) cleared (Class II).",
"target_users": [
"radiologists",
"spine surgeons",
"radiology technologists",
"clinical admins"
],
"specialties": [
"spine",
"musculoskeletal radiology",
"neuroradiology"
],
"regions_available": [
"USA",
"Germany",
"Italy",
"France",
"Spain",
"Belgium",
"Netherlands",
"Austria",
"Switzerland",
"Europe"
],
"languages_supported": [
"English"
],
"pricing_model": "subscription",
"pricing_details": "subscription priced by number of analyses; contact vendor for tiers and quotation",
"license": "commercial, proprietary",
"deployment_model": [
"on_prem",
"cloud",
"SaaS",
"hybrid"
],
"os_platforms": [
"Web",
"Windows",
"Linux"
],
"features": [
"Automated lumbar spine MRI segmentation (U-Net-like CNN)",
"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 / throughput improvements",
"Performance metrics: reduces reporting time and omissions"
],
"optional_modules": [
"Advanced analytics / research export",
"Marketplace connectors (Nuance/Blackford/Philips etc.)",
"Language packs",
"Site/facility standardization templates",
"Integration/connectors to PACS/RIS/EMR"
],
"integrations": [
"Nuance (Precision Imaging Network / AI Services Catalog)",
"Blackford Analysis",
"Philips",
"Sectra",
"Incepto",
"Deepc",
"Ferrum Health",
"PACS (DICOM-compatible)",
"RIS",
"EMR"
],
"data_standards": [
"DICOM",
"HL7 v2",
"FHIR",
"IHE",
"SNOMED CT",
"ICD-10"
],
"api_available": "yes",
"system_requirements": "DICOM-compatible PACS; Windows/Linux server for on-prem; GPU recommended for inference; or cloud-hosted SaaS access",
"compliance": [
"FDA 510(k)",
"CE mark (EU)",
"TGA (Australia)",
"ISO 27001",
"ISO 13485"
],
"certifications": [
"FDA 510(k) (K241211)",
"CE certificate (medical device)",
"TGA ARTG listing",
"ISO 13485 certificate",
"ISO 27001 certificate"
],
"security_features": [
"Encryption in transit",
"Encryption at rest",
"Role-based access control (RBAC)",
"Audit logging",
"SSO/SAML integration"
],
"privacy_features": [],
"data_residency": "",
"customers": [],
"user_reviews": [
"Reduces the time needed to read images and report findings by up to 25% with no loss in accuracy.",
"Provides volumetric analysis and quantitative spine measurements that integrate into radiology workflows.",
"Ranks highly in segmentation challenges (top overall for Dice, ASD and localization distance) and shows promise in detecting degenerative lumbar spine pathologies on MRI."
],
"ratings": [
"CE mark (MDR Class IIa) - Health AI Register",
"FDA 510(k) cleared (K241211 / K220497 referenced) - U.S. FDA"
],
"support_channels": [
"email",
"phone"
],
"training_options": [
"documentation",
"webinars",
"live_online"
],
"release_year": "2021",
"integration_partners": [
"Blackford Analysis",
"CARPL.AI",
"Deepc",
"Incepto",
"Philips Healthcare",
"Sectra",
"TeraRecon",
"Osimis"
],
"id": "P2010",
"slug": "columbo",
"type": "product",
"version": "1.0",
"last_updated": "2025-09-07",
"links_json": {
"self": "https://www.healthaidb.com/software/columbo.json"
}
}