Radiology AI Directory

FDA-cleared profile

MSK Go

Smart Alfa Teknoloji San. Ve Tic. A.S.

Authorized purpose: Assist qualified MSK-ultrasound professionals by highlighting supported joint anatomy and detection completeness on compatible adult ultrasound images; it is not a diagnostic device.

Detection and CADeUltrasound workflow
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 qualified MSK-ultrasound professionals by highlighting supported joint anatomy and detection completeness on compatible adult ultrasound images; it is not a diagnostic device.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Assist qualified MSK-ultrasound professionals by highlighting supported joint anatomy and detection completeness on compatible adult ultrasound images; it is not a diagnostic device.

Evidence takeaway

Evidence from the reviewed source record: FDA K260234 packet reports AI/ML verification on 17,746 images from 40 subjects and clinical validation on 15,600 images from 3,017 scans of 79 subjects at three US clinical sites. Endpoints were joint-view detection, anatomical-structure detection, segmentation/highlighting, and detection indicator. Reported ranges include joint-view PPA 0.95-1.00/NPA 0.98-1.00, structure PPA 0.93-0.95/NPA 0.98-0.99, indicator PPA 0.90-1.00/NPA 0.97-1.00, and mean Dice 0.80-0.84 with no individual structure below 0.70.

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 qualified MSK-ultrasound professionals by highlighting supported joint anatomy and detection completeness on compatible adult ultrasound images; it is not a diagnostic device.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Healthcare professionals trained and qualified in musculoskeletal ultrasound.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Clinical ultrasound sites; adults 18 years and older; facility type is not specified.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Anatomy visualization and segmentation assistance within the ultrasound viewing workflow; not diagnostic and not acquisition guidance.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
B-mode MSK ultrasound image stream from compatible GE HealthCare Venue Go and Venue Sprint systems; adult patients 18+; five supported joint regions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Anatomical name labels, color overlays/highlighting, and a detection indicator reflecting completeness of supported structures in the current image.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Adults 18+ only; not intended for diagnosis or to replace clinical decision-making; compatible ultrasound systems and listed joint regions are required; it does not guide image acquisition.
  • 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
K260234
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Musculoskeletal joints: shoulder, elbow, wrist/hand, knee, and ankle/foot.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-05-21
  • 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
Runs within compatible diagnostic ultrasound systems, receives the host-system image stream, and displays feedback in the ultrasound system user interface; no standalone PACS routing is established.
  • 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.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for MSK Go; 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 K260234 packet reports AI/ML verification on 17,746 images from 40 subjects and clinical validation on 15,600 images from 3,017 scans of 79 subjects at three US clinical sites. Endpoints were joint-view detection, anatomical-structure detection, segmentation/highlighting, and detection indicator. Reported ranges include joint-view PPA 0.95-1.00/NPA 0.98-1.00, structure PPA 0.93-0.95/NPA 0.98-0.99, indicator PPA 0.90-1.00/NPA 0.97-1.00, and mean Dice 0.80-0.84 with no individual structure below 0.70.
  • 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.

MSK Go regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K260234
  • Samplen=79
  • Sites3
  • IndependenceIndependence not established

K260234

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 K260234 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 K260234. 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
21Fields reviewed
9Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 0 PubMed and 1 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 0 PubMed and 1 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, 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 K260234: MSK Go

    U.S. Food and Drug Administration - Published 2026-05-21 - 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. MSK Go model card (K260234)

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

    Scope: intendedUsers, careSetting, output, limitations, 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 K260234

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

    Scope: postmarketSafety

Research history

  1. K260234 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 K252433

Sonio Detect (v3)

Sonio

Sonio Detect v3 analyzes fetal ultrasound images and clips to detect views and anatomical structures and to check labeled image-quality characteristics during acquisition or...

Modality
Ultrasound
Anatomy
Fetal anatomy
Decision
2026-03-16
Detection and CADeUltrasound workflow
FDA-cleared K250959

BioticsAI

Bioticsai, Inc.

BioticsAI assists healthcare professionals during and after fetal ultrasound acquisition and interpretation by detecting views and anatomical structures and facilitating...

Modality
Ultrasound
Anatomy
Obstetric/Fetal
Decision
2025-12-22
Detection and CADeUltrasound workflow
FDA-cleared K252007

BlineSlide

Deep Breathe, Inc.

Lung ultrasound cine processing for B-line artifact presence/absence detection.

Modality
Ultrasound
Anatomy
Chest/Lung
Decision
2025-10-06
Detection and CADeUltrasound workflow