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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K260234

510(k) cleared

MSK Go

Smart Alfa Teknoloji San. Ve Tic. A.S. · May 21, 2026 · K260234

FDA cleared the MSK Go from Smart Alfa Teknoloji San. Ve Tic. A.S. on May 21, 2026 under K260234, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 26, 2026. The decision came 115 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Smart Alfa Teknoloji San. Ve Tic. A.S. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260234?

K260234 is the FDA 510(k) for MSK Go, submitted by Smart Alfa Teknoloji San. Ve Tic. A.S.. FDA's decision date was May 21, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the MSK Go?

Smart Alfa Teknoloji San. Ve Tic. A.S., based in Ankara, is the applicant of record for K260234.

How long did the K260234 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on May 21, 2026, 115 days later.

← All decisions in May 2026