ClearRT Helical KVCT For The Radixact Treatment Delivery System

Accelerator, Linear, Medical

Accuray Incorporated

The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Clearrt Helical Kvct For The Radixact Treatment Delivery System.

Pre-market Notification Details

Device IDK202412
510k NumberK202412
Device Name:ClearRT Helical KVCT For The Radixact Treatment Delivery System
ClassificationAccelerator, Linear, Medical
Applicant Accuray Incorporated 1240 Deming Way Madison,  WI  53717
ContactKeith Picker
CorrespondentKeith Picker
Accuray Incorporated 1240 Deming Way Madison,  WI  53717
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-24
Decision Date2020-12-18

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