Cleared Special

K093391 - SIMUPLAN TREATMENT PLANNING SYSTEM

K093391 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 Special 510(k) pathway after a 54-day FDA review.

K093391 · Simuplan S.L. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
54d
Days
Class 2
Risk

K093391 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 December 23, 2009 after a review of 54 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K093391

510(k) Number K093391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2009
Decision Date December 23, 2009
Days to Decision 54 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 K093391.
RAYSTATION VERSION 1.0
K100552 · Raysearch Laboratories AB · Mar 2010
CORVUS RADIATION THERAPY PLANNING SYSTEM
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EXPLORER 4D TREATMENT PLANNING SYSTEM
K093588 · American Radiosurgery, Inc. · Jan 2010
DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
K092928 · Diversilabs, LLC · Dec 2009
XIO RTP SYSTEM
K092132 · Computerized Medical Systems, Inc. · Sep 2009
LEKSELL GAMMAPLAN
K090972 · Elekta Instrument AB · Jul 2009
K093391 · SIMUPLAN TREATMENT PLANNING SYSTEM
Download PDF FDA Summary Simuplan S.L.