XPLAN-1

Accelerator, Linear, Medical

RADIONICS SOFTWARE APPLICATIONS, INC.

The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Xplan-1.

Pre-market Notification Details

Device IDK972905
510k NumberK972905
Device Name:XPLAN-1
ClassificationAccelerator, Linear, Medical
Applicant RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington,  MA  01803 -0658
ContactLinda Talbert
CorrespondentLinda Talbert
RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington,  MA  01803 -0658
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-06
Decision Date1997-10-28
Summary:summary

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