TrueBeam, TrueBeam STx, Edge, VitalBeam

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 Truebeam, Truebeam Stx, Edge, Vitalbeam.

Pre-market Notification Details

Device IDK213977
510k NumberK213977
Device Name:TrueBeam, TrueBeam STx, Edge, VitalBeam
ClassificationAccelerator, Linear, Medical
Applicant Varian Medical Systems, Inc. 911 Hansen Way Palo Alto,  CA  94304
ContactPeter J. Coronado
CorrespondentPeter J. Coronado
Varian Medical Systems, Inc. 911 Hansen Way Palo Alto,  CA  94304
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-06-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00899475002363 K213977 000
00899475002356 K213977 000
00899475002349 K213977 000

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