Radiology AI Directory

FDA-cleared profile

CoLumbo C-Spine

Smart Soft Healthcare AD

Post-process previously acquired cervical-spine MR images to segment vertebrae and disks, calculate quantitative measurements, label out-of-range values, and export results for user review and interpretation.

MSK and boneQuantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Post-process previously acquired cervical-spine MR images to segment vertebrae and disks, calculate quantitative measurements, label out-of-range values, and export results for user review and interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Radiologists, spine surgeons, and neurosurgeons
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospitals and other medical institutions
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-processing segmentation and measurement support with user-defined threshold labeling of out-of-range measurements
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Previously acquired DICOM cervical-spine MR images from patients aged 22 years or older with adequate visualization of C2-C7.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Segmentation of C3-C7 vertebrae and C2C3-C7T1 disks; measurements based on those segmentations; threshold-based labeling of out-of-range measurements; and export of measurement results. The user remains responsible for reviewing and confirming or modifying settings and outputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Valid input requires DICOM cervical-spine MR, age 22 or older, and adequate C2-C7 visualization. Performance was not established for vertebral enumeration variants, true cervical ribs, hemivertebrae, congenital or acquired fusion, contrast studies, tumors, infections, post-operative changes, vertebral fusion, or inadequate C2 visualization; the comparison table also describes a non-pregnant patient population.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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.

FDA submission
K254015
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Cervical spine: vertebrae C3-C7 and disks C2C3 through C7T1
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-04-01
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
FDA materials establish DICOM MR input and export of measurement results for hospital/medical-institution use, but do not establish a specific PACS, RIS, EHR, hosting, or network interface.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for CoLumbo C-Spine; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
A US software performance assessment used 95 cervical-spine MR studies from 95 patients, with ground truth defined by four radiologists. Tissue-segmentation MDC was 0.90 for vertebral body sagittal, 0.84 for disk sagittal, 0.70 for disk material outside the intervertebral space sagittal, and 0.68 for focal disk material outside the intervertebral space axial. Measurement MAE was 0.72 mm for vertebral-body height, 0.90 mm for disk height, 0.72 mm for disk-material AP size, and 1.29 mm for focal disk-material AP size, with the packet's stated 95% CIs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

CoLumbo C-Spine regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K254015
  • Samplen=95
  • IndependenceIndependence not established

K254015

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K254015 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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
The exact-identifier FDA recall query returned no native recall record for K254015. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-08Last searched
22Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, acr ai central product, fda decision summary, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K254015: CoLumbo C-Spine

    U.S. Food and Drug Administration - Published 2026-04-01 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. CoLumbo C-Spine model card (K254015)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K254015

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K254015 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

FDA-cleared K251682

MuscleView 2.0

Springbok, Inc. (dba Springbok Analytics)

Automatic MRI segmentation and quantitative analysis of muscle, bone, fat, and other anatomical structures to assist visualization and measurement; not direct disease diagnosis.

Modality
MRI
Anatomy
Muscles, bones, and adipose tissue across the lower extremities and upper body from neck to hips, plus other segmented structures
Decision
2025-09-09
MSK and boneQuantification and segmentation
FDA-cleared K240793

MSKai

MSKai

Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is...

Modality
MRI
Anatomy
Lumbar spine, including vertebral bodies L1-S1, intervertebral discs, cord canal, dural sac, nerve roots, and posterior arch.
Decision
2024-12-16
MSK and boneQuantification and segmentation