IDENTIFY

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 Identify.

Pre-market Notification Details

Device IDK192968
501k NumberK192968
Device Name:IDENTIFY
ClassificationAccelerator, Linear, Medical
Applicant Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto,  CA  94304
ContactPeter J Coronado
CorrespondentPeter J Coronado
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto,  CA  94304
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-23
Decision Date2019-11-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00899475002592 K192968 000

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