Cleared Traditional

Monaco RTP System

K213787 · Elekta Solutions AB · Radiology
May 2022
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K213787 is an FDA 510(k) clearance for the Monaco RTP System, 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 May 17, 2022, 162 days after receiving the submission on December 6, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K213787 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2021
Decision Date May 17, 2022
Days to Decision 162 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