TRILOGY SYSTEM WITH RAPIDARC

Accelerator, Linear, Medical

VARIAN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Trilogy System With Rapidarc.

Pre-market Notification Details

Device IDK072916
510k NumberK072916
Device Name:TRILOGY SYSTEM WITH RAPIDARC
ClassificationAccelerator, Linear, Medical
Applicant VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY M/S E-110 Palo Alto,  CA  94304
ContactVy Tran
CorrespondentVy Tran
VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY M/S E-110 Palo Alto,  CA  94304
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-12
Decision Date2007-11-09
Summary:summary

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