LINAC-BASED STEROTACTIC RADIOSURGERY

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 Linac-based Sterotactic Radiosurgery.

Pre-market Notification Details

Device IDK923522
510k NumberK923522
Device Name:LINAC-BASED STEROTACTIC RADIOSURGERY
ClassificationAccelerator, Linear, Medical
Applicant RADIONICS SOFTWARE APPLICATIONS, INC. 2 BROOKLINE PLACE SUITE 204 Brookline,  MA  02146
ContactLinda Jalbert
CorrespondentLinda Jalbert
RADIONICS SOFTWARE APPLICATIONS, INC. 2 BROOKLINE PLACE SUITE 204 Brookline,  MA  02146
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-16
Decision Date1993-08-18

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