Cleared Traditional

ONCENTRA SIMULATION 2.3 (K090706) - FDA 510(k) Clearance

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

K090706 · Nucletron Corporation · Radiology device
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Jun 2009
Decision
90d
Days
Class 2
Risk

K090706 is an FDA 510(k) clearance for the ONCENTRA SIMULATION 2.3. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on June 15, 2009 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - 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 Nucletron Corporation devices

Submission Details

510(k) Number K090706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2009
Decision Date June 15, 2009
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 - KPQ System, Simulation, Radiation Therapy

Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K090706.
SIMVIEW 3000 CT OPTION
K953233 · Siemens Medical Solutions USA, Inc. · Nov 1996
ADVANTAGE SIM
K951830 · General Electric Co. · Nov 1995
SIMVIEW(TM) 3000
K946053 · Siemens Medical Solutions USA, Inc. · Mar 1995
ACQSIM SIMULATOR/LOCALIZER
K923851 · Philips Medical Systems (Cleveland), Inc. · Oct 1992
MEVAPLAN AND SOMADOS
K852410 · Siemens Medical Solutions USA, Inc. · Oct 1985