Accuray Precision Treatment Planning System

Accelerator, Linear, Medical

Accuray Incorporated

The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Accuray Precision Treatment Planning System.

Pre-market Notification Details

Device IDK212794
510k NumberK212794
Device Name:Accuray Precision Treatment Planning System
ClassificationAccelerator, Linear, Medical
Applicant Accuray Incorporated 1209 Deming Way Madison,  WI  53717
ContactLizhi Yu
CorrespondentLizhi Yu
Accuray Incorporated 1209 Deming Way Madison,  WI  53717
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-02
Decision Date2021-09-30

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