Cleared Traditional

K120551 - SIMUPLAN TREATMENT PLANNING SYSTEM

K120551 is an FDA 510(k) clearance for SIMUPLAN TREATMENT PLANNING SYSTEM, manufactured by Simuplan S.L.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K120551 · Simuplan S.L. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
106d
Days
Class 2
Risk

K120551 is an FDA 510(k) clearance for the SIMUPLAN TREATMENT PLANNING SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Simuplan S.L. (Rice Lake, US). The FDA issued a Cleared decision on June 8, 2012 after a review of 106 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K120551

510(k) Number K120551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2012
Decision Date June 08, 2012
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
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.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 256
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K120551.
ONQ RTS
K123357 · Oncology Systems, Inc. · Dec 2012
VITESSE 3.0
K123152 · Varian Medical Systems, Oncology Systems · Dec 2012
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
K121448 · Elekta Inc. D/B/A Nucletron Corporation · Jul 2012
RAYSTATION
K120387 · Raysearch Laboratories AB · Apr 2012
SYNGO RT INTERFACE
K120363 · Siemens Medical Solutions USA, Inc. · Mar 2012
EPIGRAY
K112723 · Dosisoft SA · Feb 2012
K120551 · SIMUPLAN TREATMENT PLANNING SYSTEM
Download PDF FDA Summary Simuplan S.L.