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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 / August 2026 / K261932

510(k) cleared

Leksell® Vantage Stereotactic System

Elekta Solutions AB · Aug 5, 2026 · K261932

FDA cleared the Leksell® Vantage Stereotactic System from Elekta Solutions AB on Aug 5, 2026 under K261932, a traditional 510(k). The device falls under product code HAW, Neurological Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 9, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

Elekta Solutions AB has 3 other decisions in the tracker over the last 12 months: K252002 (Monaco RTP System (6.3)), K252188 (EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)), K251363 (ProKnow DS).

Questions & Answers

What did FDA clear under K261932?

K261932 is the FDA 510(k) for Leksell® Vantage Stereotactic System, submitted by Elekta Solutions AB. FDA's decision date was Aug 5, 2026, under product code HAW (Neurological Stereotaxic Instrument).

Who makes the Leksell® Vantage Stereotactic System?

Elekta Solutions AB, based in Stockholm, is the applicant of record for K261932.

How long did the K261932 review take?

FDA received the submission on Jun 9, 2026 and issued its decision on Aug 5, 2026, 57 days later.

← All decisions in August 2026

Sources