VERIFICATION CONSOLE

System, Radiation Therapy, Charged-particle, Medical

VARIAN MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Verification Console.

Pre-market Notification Details

Device IDK124002
510k NumberK124002
Device Name:VERIFICATION CONSOLE
ClassificationSystem, Radiation Therapy, Charged-particle, Medical
Applicant VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY Palo Alto,  CA  94304 -1034
ContactPeter J Coronado
CorrespondentPeter J Coronado
VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY Palo Alto,  CA  94304 -1034
Product CodeLHN  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-26
Decision Date2013-02-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00856104006024 K124002 000
00856104006123 K124002 000
00856104006079 K124002 000

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