Cleared Traditional

PlanOne 1

K250963 · Cosylab Jsc, Control System Laboratory · Radiology
Nov 2025
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K250963 is an FDA 510(k) clearance for the PlanOne 1, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Cosylab Jsc, Control System Laboratory (Ljubljana, SI). The FDA issued a Cleared decision on November 20, 2025, 234 days after receiving the submission on March 31, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K250963 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2025
Decision Date November 20, 2025
Days to Decision 234 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050