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Varian Medical Systems Imaging Laboratory GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30030949123003094912Varian Medical Systems Imaging Laboratory GmbH1N2027-01-01Taefernstrasse 7 Daettwil, Argovia Aargau CH CH-5405

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
80181037335513K253026Respiratory Gating for Scanners (2.1)JAK2026-06-04
80181814783113K252919IDENTIFY (5.0)IYE2025-12-16
80181977076667K250099Mobius3D (4.1)IYE2025-05-16
80181932163241K242957Identify (4.0)IYE2025-02-07
80181667485743K242874Gating Reflector BlockJAK2024-11-21
80181481398843K242463ARIA Radiation Therapy Management System (18.1)MUJ2024-12-13
80181477740601K242378Eclipse Treatment Planning System (18.1)MUJ2024-12-11
80181197113803K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)IYE2024-04-30
80181836418789K230699ARIA Radiation Therapy Management (v18.0)IYE2023-04-10
80181297393525K230576IDENTIFYIYE2023-07-25
80181255110599K230557Eclipse Treatment Planning System (v18.0)MUJ2023-05-26
80181356879613K221408ARIA Radiation Therapy Management (v16.1 MR3)IYE2022-06-17
80181023132637K213927Respiratory Gating for Scanners v2.0JAK2022-01-14
80181507326991K212294Ethos Treatment Management, Ethos Treatment PlanningIYE2021-08-20
80181723298030K210835IdentifyIYE2021-04-20
80181314794691K203669Mobius3DIYE2021-01-14
80181866205990K201607Eclipse Treatment Planning System v16.1MUJ2020-07-10
80181016460499K200608Eclipse Treatment Planning System v16.0MUJ2020-04-03
80181134592023K200608Eclipse Treatment Planning System v16.0MUJ2020-04-03
80181240214178K192968IDENTIFYIYE2019-11-12
80181053686007K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonIYE2020-02-10
80181614231899K190137IdentifyIYE2019-07-10
80181281255750K181145Eclipse Treatment Planning SystemMUJ2018-05-18
80181882678344K173838ARIA Radiation Therapy ManagementIYE2018-01-17
80181375057051K172163Eclipse Treatment Planning SystemMUJ2017-08-15
80181026628070K152393Eclipse Treatment Planning SystemMUJ2015-09-18
80181157142985K151533Respiratory Gating for ScannersJAK2015-08-13
80181712812792K141230DOSELAB PROIYE2014-08-27
80181939365845K102024RPM RESPIRATORY GATING SYSTEMIYE2010-10-15
80181514022482K091209PORTALVISION ADVANCED IMAGINGIYE2009-06-23
80181191203810K042720ON-BOARD IMAGER DEVICEIYE2004-10-29
80181683472889
80181710706144

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE212025-12-16
MUJ102024-12-13
JAK42026-06-04

GUDID#