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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 / September 2025 / K250986

510(k) cleared

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Mevion Medical Systems, Inc. · Sep 12, 2025 · K250986

FDA cleared the S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) from Mevion Medical Systems, Inc. on Sep 12, 2025 under K250986, a traditional 510(k). The device falls under product code LHN, System, Radiation Therapy, Charged-Particle, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 31, 2025. The decision came 165 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mevion Medical Systems, Inc. has one other decision in the tracker over the last 12 months: K253406 (S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)).

Questions & Answers

What did FDA clear under K250986?

K250986 is the FDA 510(k) for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT), submitted by Mevion Medical Systems, Inc.. FDA's decision date was Sep 12, 2025, under product code LHN (System, Radiation Therapy, Charged-Particle, Medical).

Who makes the S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)?

Mevion Medical Systems, Inc., based in Littleton, MA, is the applicant of record for K250986.

How long did the K250986 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on Sep 12, 2025, 165 days later.

← All decisions in September 2025

Sources