XKNIFE-3

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 Xknife-3.

Pre-market Notification Details

Device IDK953482
510k NumberK953482
Device Name:XKNIFE-3
ClassificationAccelerator, Linear, Medical
Applicant RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington,  MA  01803 -2591
ContactLinda Jalbert
CorrespondentLinda Jalbert
RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington,  MA  01803 -2591
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-24
Decision Date1995-10-25

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