MSK Go— 510(k) K260234

Substantially Equivalent

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

FDA 510(k) clearance K260234 for MSK Go, Substantially Equivalent on 2026-05-21. Applicant: Smart Alfa Teknoloji San. Ve Tic. A.S.. Device class: 2.

Clearance details

Applicant: Smart Alfa Teknoloji San. Ve Tic. A.S.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-01-26
Decision date: 2026-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ankara, TR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.