Radiology AI Directory

FDA-cleared profile

ScanDiags Ortho L-Spine MR-Q

ScanDiags AG

Semi-automatic lumbar MRI segmentation and area and distance measurements with radiologist-approved PDF report to PACS; adjunct only.

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
Semi-automatic lumbar MRI segmentation and area and distance measurements with radiologist-approved PDF report to PACS; adjunct only.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Intended users
Radiologists and other trained healthcare professionals reviewing lumbar MRI examinations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Care setting and population
Adult lumbar MRI interpretation and reporting workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Workflow role
Segmentation and measurement aid that produces a report for radiologist approval; it is not intended to make a diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Required input
DICOM lumbar spine MR studies from adults, without the excluded contrast, pregnancy, postoperative-complication or infection scenarios described in the labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Output and human action
Segmentations and area or distance measurements for vertebral bodies, discs, neuroforamina and thecal sac, with a PDF report containing overlays sent to PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Limitations
The exact labeling excludes pregnancy, contrast examinations, postoperative complications and infection, and states that the software does not diagnose disease; it is intended as an adjunct to professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

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
K242607
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Anatomy
Spine
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-02-21
  • 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
The exact submission describes a PDF report with overlays sent to PACS. The company-issued ImagoPlus family release describes standardized reports and integration into radiology operations, but it predates the exact clearance and is not treated as a current K242607 interface specification.
  • Public source
  • Product family
  • Checked 2026-09-07
Deployment and data flow
The reviewed FDA materials describe processing lumbar MR studies and returning a PDF report with overlays to PACS; current hosting and site architecture were not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

Current security scope, attestations and contract terms were not established; FDA labeling statements are preserved separately.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

PACS report delivery

The exact labeling describes a PDF report with overlays sent to PACS for radiologist approval.

exact submission · checked 2026-09-06
Source

Family MRI hardware and operations context

The company-issued ImagoPlus release describes compatibility across MRI hardware and integration into radiology operations; it is family-level and predates the exact clearance.

product family · checked 2026-09-07
Source

Human approval boundary

The exact product is an adjunct: the radiologist reviews the segmentations, measurements and report rather than delegating diagnosis to the software.

exact submission · checked 2026-09-06
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
The FDA summary describes two validation cohorts, including 100 studies for segmentation and a separate 101-study, seven-site measurement cohort; reported agreement included vertebral-body area ICC 0.95 and vertebral-body Dice similarity coefficient 0.95.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
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.

Vertebral-body area intraclass correlation

0.95 ICC

  • EndpointAutomated versus radiologist vertebral-body area
  • PopulationLumbar MR segmentation cohort of 100 studies
  • Tested versionScanDiags Ortho L-Spine MR-Q release reviewed in K242607
Source

Vertebral-body segmentation Dice similarity coefficient

0.95 Dice

  • EndpointAutomated versus radiologist vertebral-body segmentation
  • PopulationLumbar MR segmentation cohort of 100 studies
  • Tested versionScanDiags Ortho L-Spine MR-Q release reviewed in K242607
Source

Neuroforamen segmentation Dice similarity coefficient

0.86 Dice

  • EndpointAutomated versus radiologist neuroforamen segmentation
  • PopulationLumbar MR segmentation cohort of 100 studies
  • Tested versionScanDiags Ortho L-Spine MR-Q release reviewed in K242607
Source

Ortho L-Spine MR-Q segmentation validation

  • DesignRetrospective segmentation validation against three U.S. board-certified musculoskeletal radiologists
  • Population100 individual lumbar MR studies from hospital groups in Missouri and North Carolina across GE, Siemens and Philips systems
  • Scopeexact submission
  • Tested versionScanDiags Ortho L-Spine MR-Q release reviewed in K242607
  • Samplen=100
  • IndependenceSponsor or vendor study

K242607 FDA 510(k) summary

The summary reports a second measurement cohort separately; this record is limited to the 100-study segmentation cohort.

Source

Ortho L-Spine MR-Q measurement validation

  • DesignRetrospective multi-site measurement validation against radiologist reference
  • Population101 lumbar MR studies across seven U.S. sites and multiple MRI manufacturers
  • Scopeexact submission
  • Tested versionScanDiags Ortho L-Spine MR-Q release reviewed in K242607
  • Samplen=101
  • Sites7
  • IndependenceSponsor or vendor study

K242607 FDA 510(k) summary measurement cohort

The exact FDA summary describes the measurement cohort separately from the 100-study segmentation cohort.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

No numeric price was published in the reviewed sources.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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.

Human reviewedStatus
2026-09-07Last searched
23Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The stored candidate metadata contained empty PubMed and clinical-trial ID arrays; metadata was screened, not full-text or registry-reviewed. The stored recall candidate record was empty and no event 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, vendor product page, vendor press release, peer reviewed publication, clinical trial registry, recall database, 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. K242607 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. ScanDiags Ortho L-Spine MR-Q model card (K242607)

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

    Scope: intendedUsers, careSetting, output, 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. FDA 510(k) decision record and summary reviewed for ScanDiags Ortho L-Spine MR-Q, K242607

    U.S. Food and Drug Administration - Published 2025-02-21 - Accessed 2026-09-06

    Scope: identity, intended_use, performance, limitations, implementation, cybersecurity_labeling

  8. ScanDiags accelerates commercialization of the ImagoPlus medical imaging AI platform

    ScanDiags Health Technologies Inc. (company-issued release via Newsfile) - Published 2024-02-05 - Accessed 2026-09-07

    Scope: product_family, clinical_workflow, reporting, MRI_integration

Research history

  1. K242607 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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