Cleared Traditional

Monaco Rtp System

K202789 · Elekta Solutions AB · Radiology
Feb 2021
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K202789 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, 2021, 154 days after receiving the submission on September 22, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K202789 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2020
Decision Date February 23, 2021
Days to Decision 154 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