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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 / February 2026 / K252002

510(k) cleared

Monaco RTP System (6.3)

Elekta Solutions AB · Feb 19, 2026 · K252002

FDA cleared the Monaco RTP System (6.3) from Elekta Solutions AB on Feb 19, 2026 under K252002, a traditional 510(k). The device falls under product code MUJ, System, Planning, Radiation Therapy Treatment, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 27, 2025. The decision came 237 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Elekta Solutions AB has 3 other decisions in the tracker over the last 12 months: K261932 (Leksell® Vantage Stereotactic System), 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 K252002?

K252002 is the FDA 510(k) for Monaco RTP System (6.3), submitted by Elekta Solutions AB. FDA's decision date was Feb 19, 2026, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the Monaco RTP System (6.3)?

Elekta Solutions AB, based in Stockholm, is the applicant of record for K252002.

How long did the K252002 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Feb 19, 2026, 237 days later.

← All decisions in February 2026

Sources