Company profile

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

Smart Alfa Teknoloji San. Ve Tic. A.S. has 2 AI-enabled medical devices on the FDA list. The first decision was on August 15, 2025 and the most recent on May 21, 2026 (MSK Go). Its most common review panel is Radiology (1 device).

2AI devices

2025First decision

2026Latest decision

2Specialties

Timeline

May 21, 2026 · 510(k) K260234MSK Go · Radiology · QIH
August 15, 2025 · 510(k) K250818Nerveblox · Anesthesiology · QRG