MSK Go— 510(k) K260234
Substantially EquivalentSmart 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.
Summary
Smart Alfa Teknoloji filed MSK Go under QIH, automated radiological image processing software. The record doesn't expand "MSK".
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Smart Alfa filed from Ankara, Turkey. Review took 115 calendar days (January 26 to May 21, 2026).
Clearance details
- Applicant
- Smart Alfa Teknoloji San. Ve Tic. A.S.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ankara, TR
Recent devices under product code QIH
view allMore clearances from Smart Alfa Teknoloji San. Ve Tic. A.S.
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