CYBERKNIFE SYSTEM

Accelerator, Linear, Medical

ACCURAY, INC.

The following data is part of a premarket notification filed by Accuray, Inc. with the FDA for Cyberknife System.

Pre-market Notification Details

Device IDK011024
510k NumberK011024
Device Name:CYBERKNIFE SYSTEM
ClassificationAccelerator, Linear, Medical
Applicant ACCURAY, INC. 570 DEL REY AVE. Sunnyvale,  CA  94085
ContactE. Bruce Floyd
CorrespondentE. Bruce Floyd
ACCURAY, INC. 570 DEL REY AVE. Sunnyvale,  CA  94085
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-04
Decision Date2001-08-10

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