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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 / K250318

510(k) cleared

Planmed XFI

Planmed OY · Sep 26, 2025 · K250318

FDA cleared the Planmed XFI from Planmed OY on Sep 26, 2025 under K250318, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code SFV, X-Ray, Computed Tomography, Cone-Beam, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 4, 2025. The decision came 234 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 Planmed OY in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250318?

K250318 is the FDA 510(k) for Planmed XFI, submitted by Planmed OY. FDA's decision date was Sep 26, 2025, under product code SFV (X-Ray, Computed Tomography, Cone-Beam).

Who makes the Planmed XFI?

Planmed OY, based in Helsinki, is the applicant of record for K250318.

How long did the K250318 review take?

FDA received the submission on Feb 4, 2025 and issued its decision on Sep 26, 2025, 234 days later.

← All decisions in September 2025