Release and scope verification
Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K241211.
exact submission · checked 2026-09-04FDA-cleared profile
CoLumbo
Smart Soft Healthcare
CoLumbo version 3 is an image post-processing and measurement tool that provides quantitative measurements of the lumbar spine from previously acquired lumbar-spine MR images.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- CoLumbo version 3 is an image post-processing and measurement tool that provides quantitative measurements of the lumbar spine from previously acquired lumbar-spine MR images.
- Intended users
- Radiologists and neuro- or spine surgeons at hospitals and other medical institutions.
- Care setting and population
- Hospitals and other medical institutions performing lumbar-spine MRI review.
- Workflow role
- Post-processing, segmentation, measurement, threshold labeling, and report support for lumbar-spine MRI.
- Required input
- Previously acquired DICOM lumbar-spine MR images in adults aged 18 years and older.
- Output and human action
- Segmentations, quantitative spine measurements, threshold-based labels, user-approved annotations, and an exportable report.
- Limitations
- The FDA labeling excludes or limits use for pregnancy, contrast MRI, postoperative complications, tumors, infections, and other stated conditions. The user must review, revise, and approve measurements; the software is not a diagnosis or treatment.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The FDA package describes DICOM lumbar MR input and report export after user review and approval.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Not established in reviewed sources
Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Training and support
- Use by radiologists and neuro- or spine surgeons at hospitals and other medical institutions. Follow the exact labeling, local training, supervision, and escalation requirements.
- Monitoring and change control
- Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K241211.
Deployment boundary
The exact public deployment boundary is incomplete; confirm hosting, data flow, availability, upgrades, security, service, and downtime locally.
exact submission · checked 2026-09-04Interoperability acceptance
The FDA package describes DICOM lumbar MR input and report export after user review and approval.
exact submission · checked 2026-09-04Clinical acceptance
Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K241211.
exact submission · checked 2026-09-04Economic evaluation
Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.
product family · checked 2026-09-04Lifecycle monitoring
Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.
exact submission · checked 2026-09-04Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- K241211 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for CoLumbo version 3. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
- Reported sensitivity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
- Reported specificity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K241211 FDA evidence package for CoLumbo
FDA 510(k) decision evidence and product verification for the exact submission. · Lumbar spine
exact submission · Tested version: CoLumbo version 3 · Sponsor or vendor studyK241211
FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.
Economics and lifecycle
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Not established in reviewed sources
No public list price or commercial contract for the exact submission and version was identified.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
No product-specific code
No exact-product reimbursement determination identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- No record matched K241211 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Verify pricing and total cost: No public list price or commercial contract for the exact submission and version was identified.
- Verify reimbursement and coding relevance: No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
11Source classes checked
16Reviewed PubMed leads
10Reviewed trial leads
0Unreviewed FDA recall leads
No evidence was promoted. PMID 38349415 names CoLumbo but does not identify version 3 or K241211; every other PubMed and trial result is an unrelated alias match. The current discovery snapshot contains 16 PubMed and 10 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-04.
- FDA 510(k) decision material K241211: CoLumbo U.S. Food and Drug Administration · 2026-09-04
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- CoLumbo model card (K241211) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
Alternatives
Related tools to compare
FDA-cleared K261405
ANDI 2.2
Imeka Solutions, Inc.
ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained...
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2026-05-28
FDA-cleared K261273
Neurophet AQUA
Neurophet., Inc.
Neurophet AQUA is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images; volumetric...
- Modality
- MRI
- Anatomy
- Brain; segmentable structures and lesions
- Decision
- 2026-05-15
FDA-cleared K260032
Morph
BeauBrain Healthcare, Inc.
Morph automatically labels, visualizes, and volumetrically quantifies segmentable brain structures from MR images and may compare measurements with reference percentile data; it...
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2026-05-13
FDA-cleared K254015
CoLumbo C-Spine
Smart Soft Healthcare AD
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
- Modality
- MRI
- Anatomy
- Spine
- Decision
- 2026-04-01