Cleared Traditional

Monaco RTP System

K223233 · Elekta Solutions AB · Radiology
Feb 2023
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K223233 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 February 23, 2023, 127 days after receiving the submission on October 19, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K223233 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2022
Decision Date February 23, 2023
Days to Decision 127 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