ONCENTRA SIMULATION 2.3

System, Simulation, Radiation Therapy

NUCLETRON CORPORATION

The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Oncentra Simulation 2.3.

Pre-market Notification Details

Device IDK090706
510k NumberK090706
Device Name:ONCENTRA SIMULATION 2.3
ClassificationSystem, Simulation, Radiation Therapy
Applicant NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia,  MD  21046
ContactElaine Colby
CorrespondentElaine Colby
NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia,  MD  21046
Product CodeKPQ  
CFR Regulation Number892.5840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-17
Decision Date2009-06-15
Summary:summary

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