VITESSE 3.0

System, Planning, Radiation Therapy Treatment

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 Vitesse 3.0.

Pre-market Notification Details

Device IDK123152
510k NumberK123152
Device Name:VITESSE 3.0
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS 911 HANSEN WAY Palo Alto,  CA  94304
ContactVy Tran
CorrespondentVy Tran
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS 911 HANSEN WAY Palo Alto,  CA  94304
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-09
Decision Date2012-12-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850800006012 K123152 000

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