Radiology AI Directory

FDA-cleared profile

MuscleView

Springbok, Inc.

Authorized purpose: Automatically segment lower-extremity muscle and bone structures from MRI in patients aged 18 years and older and provide derived muscle volume, bone volume, intramuscular fat percentage, and left/right asymmetry metrics; the output is not direct disease 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: Automatically segment lower-extremity muscle and bone structures from MRI in patients aged 18 years and older and provide derived muscle volume, bone volume, intramuscular fat percentage, and left/right asymmetry metrics; the output is not direct disease diagnosis.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Automatically segment lower-extremity muscle and bone structures from MRI in patients aged 18 years and older and provide derived muscle volume, bone volume, intramuscular fat percentage, and left/right asymmetry metrics; the output is not direct disease diagnosis.

Evidence takeaway

Evidence from the reviewed source record: FDA AI validation used 1,658 training scans from 1,294 subjects and 148 validation scans from 148 subjects; 70% of validation data came from 19 new sites and the validation set covered Siemens, GE, Philips, Canon, and other or unknown MRI systems. Expert manual segmentations were the reference standard. Each of the 80 supported structures and reported healthy, patient, manufacturer, age, and biologic-sex subgroups passed prespecified acceptance criteria using either Dice similarity coefficient or volume difference relative to interobserver variability. The reviewed text does not provide a single overall sensitivity, specificity, AUC, or one pooled numeric result.

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
Automatically segment lower-extremity muscle and bone structures from MRI in patients aged 18 years and older and provide derived muscle volume, bone volume, intramuscular fat percentage, and left/right asymmetry metrics; the output is not direct disease diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Physicians trained to interpret MRI images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Private-network workstation with an advanced GPU running the service and a web-based interface; the specific clinical facility type is not stated.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-acquisition MRI preprocessing and 3D volume segmentation followed by interactive visualization and metric review; segmentation results must be reviewed and edited using appropriate software.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
MRI DICOM data from one or more study series, preprocessed into continuous 3D volumes for lower-extremity musculoskeletal segmentation; validation covered multiple manufacturers, field strengths, series settings, and resolutions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Automatic segmentations and an interactive 3D model viewer for the supported muscles and bones, with segmentation volume, muscle volume, bone volume, intramuscular fat infiltration or percentage, limb-side asymmetry, and other derived metrics.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The labeled scope is patients aged 18 years and older and excludes patients with tumors in the lower limb. Outputs are only segmentation and derived metrics, cannot directly guide disease diagnosis, and require physician review and editing with appropriate software. The FDA summary does not establish PACS, RIS, EHR, or cloud deployment.
  • 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
K241331
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Lower extremities; 72 muscles and 8 bones including pelvis, femur, tibia, and fibula, bilaterally
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-10-01
  • 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
Processes DICOM data on a private-network GPU workstation as a service and uses a web-based interface for data transfer, automated segmentation, and visualization. Specific hospital-system interfaces and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-cloud
  • 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.

ACR exact-submission catalog context

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

exact submission ยท 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 AI validation used 1,658 training scans from 1,294 subjects and 148 validation scans from 148 subjects; 70% of validation data came from 19 new sites and the validation set covered Siemens, GE, Philips, Canon, and other or unknown MRI systems. Expert manual segmentations were the reference standard. Each of the 80 supported structures and reported healthy, patient, manufacturer, age, and biologic-sex subgroups passed prespecified acceptance criteria using either Dice similarity coefficient or volume difference relative to interobserver variability. The reviewed text does not provide a single overall sensitivity, specificity, AUC, or one pooled numeric result.
  • 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.

MuscleView regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K241331
  • Samplen=148
  • IndependenceIndependence not established

K241331

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 K241331 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 K241331. 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
22Fields 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 K241331: MuscleView

    U.S. Food and Drug Administration - Published 2024-10-01 - 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. MuscleView model card (K241331)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies

  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 K241331

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

    Scope: postmarketSafety

Research history

  1. K241331 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

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
MSK and boneQuantification and segmentation
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