VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR

Accelerator, Linear, Medical

VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS

The following data is part of a premarket notification filed by Varian Medical Systems, Oncology Systems with the FDA for Varian Unique Single Energy Linear Accelerator.

Pre-market Notification Details

Device IDK101751
510k NumberK101751
Device Name:VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
ClassificationAccelerator, Linear, Medical
Applicant VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS 3100 HANSEN WAY Palo Alto,  CA  94304
ContactVy Tran
CorrespondentVy Tran
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS 3100 HANSEN WAY Palo Alto,  CA  94304
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-22
Decision Date2010-08-10
Summary:summary

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