Cleared Traditional

K202789 - Monaco Rtp System

K202789 is an FDA 510(k) clearance for Monaco Rtp System, manufactured by Elekta Solutions AB. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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

K202789 is an FDA 510(k) clearance for the Monaco Rtp System. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on February 23, 2021 after a review of 154 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Elekta Solutions AB devices

FDA 510(k) Submission Details - K202789

510(k) Number K202789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 107d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

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All 144
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