TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE

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 With External System Gating Interface.

Pre-market Notification Details

Device IDK081188
510k NumberK081188
Device Name:TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-28
Decision Date2008-07-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.