Cleared Traditional

MONACO RTP SYSTEM (K071938) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071938 · Computerized Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
80d
Days
Class 2
Risk

K071938 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 Computerized Medical Systems, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 1, 2007 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Computerized Medical Systems, Inc. devices

Submission Details

510(k) Number K071938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2007
Decision Date October 01, 2007
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 106
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K071938.
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ECLIPSE TREATMENT PLANNING SYSTEM
K073020 · Varian Medical Systems, Inc. · Dec 2007
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
K071760 · Varian Medical Systems, Inc. · Nov 2007
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K071873 · Varian Medical Systems, Inc. · Aug 2007
COHERENCE DOSIMETRIST, MODEL 2.2
K061097 · Siemens Medical Solutions USA, Inc. · Jun 2006
VITESSE 2.0
K051497 · Varian Medical Systems, Inc. · Jul 2005