Cleared Traditional

K260234 - MSK Go (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence.

K260234 · Smart Alfa Teknoloji San. Ve Tic. A.S. · Radiology device
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May 2026
Decision
115d
Days
Class 2
Risk

K260234 is an FDA 510(k) clearance for the MSK Go. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Smart Alfa Teknoloji San. Ve Tic. A.S. (Ankara, TR). The FDA issued a Cleared decision on May 21, 2026 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Smart Alfa Teknoloji San. Ve Tic. A.S. devices

Submission Details

510(k) Number K260234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2026
Decision Date May 21, 2026
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT07336407 Completed Interventional Industry-sponsored

Data Collection for the Validation of an Artificial Intelligence Software to Support Musculoskeletal Ultrasound Examination

Data Collection for the Validation of an AI Software to Support MSK Ultrasound Examination

79
Patients (actual)
3
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Ultrasound Imaging of Anatomical Structures
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Smart Alfa Teknoloji San. ve Tic. A.S. (industry)
Started 2025-09-01 → Primary completion 2025-10-31 → Completed 2025-11-30
Primary outcome
Rate of spatial (area) overlap of anatomical structure areas on the ultrasound image
Secondary outcome
Rate of correctly assigning anatomical structure completeness level for any scan view of the joint
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - QIH Automated Radiological Image Processing Software

All 295
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K260234.
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BAC
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Neurophet SCALE PET
K252563 · Neurophet., Inc. · May 2026
SubtleHD-CT (1.x)
K254120 · Subtle Medical, Inc. · May 2026