Cleared Traditional

Monaco RTP System (6.3)

K252002 · Elekta Solutions AB · Radiology
Feb 2026
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K252002 is an FDA 510(k) clearance for the Monaco RTP System (6.3), a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on February 19, 2026, 237 days after receiving the submission on June 27, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K252002 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date February 19, 2026
Days to Decision 237 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