Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
MSKai
MSKai
Authorized purpose: Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is not a diagnostic device.
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: Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is not a diagnostic device.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is not a diagnostic device.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Lumbar spine, including vertebral bodies L1-S1, intervertebral discs, cord canal, dural sac, nerve roots, and posterior arch. Input: Previously acquired T2-weighted DICOM lumbar-spine MRI images from patients 18 and older. The packet excludes pregnancy, postoperative complications, tumors, infections, and complex hardware.
- Who uses it? Intended users: Physicians, including radiologists and neuro/orthopedic spine surgeons; the user must review and authorize measurements and draft reports.
- What does the software produce? Output: Qualitative image viewing; segmentation and labels for lumbar-spine structures; quantitative measurements such as disc protrusion, intervertebral angles, vertebral-body and disc heights, anterolisthesis/retrolisthesis, lordotic angle, dural-sac diameter, and report export. User-confirmed settings and measurements control storage and reporting.
- What is its most important limitation? Key limitation: Not for diagnosis or treatment recommendation; segmentations are not final outputs; the user must confirm or reject measurements, inspect labels and segmentations, and review and approve reports. Only the stated T2-weighted DICOM lumbar-spine inputs and labeled patient restrictions are supported.
Clinical takeaway
Clinical role: Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is not a diagnostic device.
Evidence takeaway
Evidence from the reviewed source record: FDA K240793 reports three independent data sets: 255 patient images for ground-truth development, 575 for pass/fail criteria, and 238 testing patients/studies from five U.S. sites on GE, Philips, and Siemens 1.5T/3.0T MRI systems. Four independent experts compared unedited software outputs with expert ground truth. Endpoints were structure segmentation mean Dice/MDC and measurement mean absolute error (MAE); listed mean Dice values ranged from 0.911 to 0.993 with structure-specific 95% CIs, and measurement MAEs were below structure-specific limits. The packet states no human clinical study was conducted for premarket clearance.
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
- Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is not a diagnostic device.
- Intended users
- Physicians, including radiologists and neuro/orthopedic spine surgeons; the user must review and authorize measurements and draft reports.
- Care setting and population
- Hospitals and other medical institutions using a lumbar-spine MRI post-processing workflow; adults 18 and older.
- Workflow role
- Post-processing segmentation, labeling, measurement, and reporting aid; the user controls settings and confirms outputs.
- Required input
- Previously acquired T2-weighted DICOM lumbar-spine MRI images from patients 18 and older. The packet excludes pregnancy, postoperative complications, tumors, infections, and complex hardware.
- Output and human action
- Qualitative image viewing; segmentation and labels for lumbar-spine structures; quantitative measurements such as disc protrusion, intervertebral angles, vertebral-body and disc heights, anterolisthesis/retrolisthesis, lordotic angle, dural-sac diameter, and report export. User-confirmed settings and measurements control storage and reporting.
- Limitations
- Not for diagnosis or treatment recommendation; segmentations are not final outputs; the user must confirm or reject measurements, inspect labels and segmentations, and review and approve reports. Only the stated T2-weighted DICOM lumbar-spine inputs and labeled patient restrictions are supported.
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
- DICOM image input and qualitative/quantitative report export are established; the packet does not establish a specific PACS, RIS, EHR, or routing interface.
- 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
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for MSKai; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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 K240793 reports three independent data sets: 255 patient images for ground-truth development, 575 for pass/fail criteria, and 238 testing patients/studies from five U.S. sites on GE, Philips, and Siemens 1.5T/3.0T MRI systems. Four independent experts compared unedited software outputs with expert ground truth. Endpoints were structure segmentation mean Dice/MDC and measurement mean absolute error (MAE); listed mean Dice values ranged from 0.911 to 0.993 with structure-specific 95% CIs, and measurement MAEs were below structure-specific limits. The packet states no human clinical study was conducted for premarket clearance.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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.
MSKai regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K240793
- Samplen=238
- IndependenceIndependence not established
K240793
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K240793 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K240793. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K240793 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
23Fields 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
-
FDA K240793: MSKai
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
MSKai model card (K240793)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K240793
Scope: postmarketSafety
Research history
-
K240793 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Related tools to compare
FDA-cleared K254015
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...
- Modality
- MRI
- Anatomy
- Cervical spine: vertebrae C3-C7 and disks C2C3 through C7T1
- Decision
- 2026-04-01
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
FDA-cleared K242607
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.
- Modality
- MRI
- Anatomy
- Spine
- Decision
- 2025-02-21
FDA-cleared K241108
RemedyLogic AI MRI Lumbar Spine Reader
Remedy Logic Inc.
Post-processes and measures previously acquired DICOM lumbar-spine MR images through segmentation, measurement, and report export.
- Modality
- MRI
- Anatomy
- Lumbar spine
- Decision
- 2024-10-30