Radiology AI Directory

FDA-cleared profile

CoLumboX

Smart Soft Healthcare AD

Authorized purpose: Post-processing segmentation, measurement, threshold labeling, and export of quantitative lumbar-spine measurements to support clinical review; not diagnosis.

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.

Product overview

Start with the essentials

Authorized purpose: Post-processing segmentation, measurement, threshold labeling, and export of quantitative lumbar-spine measurements to support clinical review; not diagnosis.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Post-processing segmentation, measurement, threshold labeling, and export of quantitative lumbar-spine measurements to support clinical review; not diagnosis.

Evidence takeaway

Evidence from the reviewed source record: FDA packet: software verification/validation plus an external clinical-data software performance assessment of 100 image studies from 100 patients across different genders, ages, and racial groups. Software output and physician-with/without-software output were compared with ground truth defined by three radiologists for segmentations and measurements; no numeric sensitivity, specificity, or AUC was disclosed.

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-processing segmentation, measurement, threshold labeling, and export of quantitative lumbar-spine measurements to support clinical review; not diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Radiologists and neuro- and spine surgeons at hospitals and other medical institutions
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospitals and other medical institutions; adult lumbar-spine radiograph workflow
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-processing segmentation and measurement support with user-controlled thresholds and clinician review before reporting or interpretation
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Previously acquired DICOM lumbar-spine radiograph x-ray images from patients aged 18 or older; the labeled input excludes pregnancy, post-operative complications, tumors, and infections.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Segmentation of vertebrae and sacrum; quantitative spine and spondylolisthesis-slippage measurements; threshold-based labeling of out-of-range measurements; and exportable measurement results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The output is a starting point for clinical workflow and is not a diagnosis or treatment recommendation. Users confirm or modify settings and review measurements. Use is limited to adult DICOM x-ray images; pregnancy, post-operative complications, tumors, and infections are unsupported.
  • 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
K250367
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Lumbar spine, including vertebrae and sacrum
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-05-28
  • 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
Processes previously acquired DICOM images and exports measurement results; the FDA packet does not establish a specific PACS, RIS, or EHR interface or a GE-only restriction.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

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 CoLumboX; 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
FDA packet: software verification/validation plus an external clinical-data software performance assessment of 100 image studies from 100 patients across different genders, ages, and racial groups. Software output and physician-with/without-software output were compared with ground truth defined by three radiologists for segmentations and measurements; no numeric sensitivity, specificity, or AUC was disclosed.
  • 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.

CoLumboX regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K250367
  • Samplen=100
  • IndependenceIndependence not established

K250367

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 K250367 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 K250367. 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
2026-09-20Last searched
24Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 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 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 K250367: CoLumboX

    U.S. Food and Drug Administration - Published 2025-05-28 - 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. CoLumboX model card (K250367)

    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 K250367

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

    Scope: postmarketSafety

Research history

  1. K250367 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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