CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

Accelerator, Linear, Medical

ACCURAY INCORPORATED

The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Cyberknife Robotic Radiosurgery System.

Pre-market Notification Details

Device IDK102650
510k NumberK102650
Device Name:CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
ClassificationAccelerator, Linear, Medical
Applicant ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale,  CA  94089
ContactAnne Schlagenhaft
CorrespondentAnne Schlagenhaft
ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale,  CA  94089
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-14
Decision Date2010-11-17
Summary:summary

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