Syngo.via RT Image Suite

System, Planning, Radiation Therapy Treatment

Siemens Medical Solutions USA Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Syngo.via Rt Image Suite.

Pre-market Notification Details

Device IDK211379
510k NumberK211379
Device Name:Syngo.via RT Image Suite
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Siemens Medical Solutions USA Inc. 810 Innovation Drive Knoxville,  TN  37932
ContactClayton Ginn
CorrespondentClayton Ginn
Siemens Medical Solutions USA Inc. 810 Innovation Drive Knoxville,  TN  37932
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-04
Decision Date2021-07-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869267425 K211379 000

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