Smart Segmentation - Knowledge Based Contouring

GUDID 00856100006011

Varian Medical Systems Imaging Laboratory GmbH

Radiation therapy software
Primary Device ID00856100006011
NIH Device Record Keyf2a9d36b-be6c-4022-a420-f45ef5c56dec
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart Segmentation - Knowledge Based Contouring
Version Model Number15.0
Company DUNS482243784
Company NameVarian Medical Systems Imaging Laboratory GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856100006011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUJSystem,planning,radiation therapy treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

Devices Manufactured by Varian Medical Systems Imaging Laboratory GmbH

00856100006196 - Respiratory Gating for Scanners (RGSC)2022-04-29
00856100006127 - ARIA Radiation Therapy Management Software2020-01-24
00856100006097 - ARIA Radiation Therapy Management Software2019-11-18
00856100006110 - ARIA Radiation Therapy Management Software2019-11-18
00856100006004 - ARIA Radiation Therapy Management2018-07-06 RTM
00856100006011 - Smart Segmentation - Knowledge Based Contouring2018-07-06
00856100006011 - Smart Segmentation - Knowledge Based Contouring2018-07-06
00856100006028 - Respiratory Gating for Scanners (RGSC)2018-07-06 RGSC

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