PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM

System, Applicator, Radionuclide, Remote-controlled

NUCLETRON-OLDELFT CORP.

The following data is part of a premarket notification filed by Nucletron-oldelft Corp. with the FDA for Plato Brachytheraphy Treatment Planning System.

Pre-market Notification Details

Device IDK915622
510k NumberK915622
Device Name:PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia,  MD  21045
ContactA. M Mount
CorrespondentA. M Mount
NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia,  MD  21045
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-16
Decision Date1992-09-25

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