Varian Acuity with Conebeam Computed Tomography TM64001000

GUDID 00856545006010

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy simulation system
Primary Device ID00856545006010
NIH Device Record Key2b7fbd19-46ed-412e-8a89-8447a2a3429a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVarian Acuity with Conebeam Computed Tomography
Version Model Number2.1
Catalog NumberTM64001000
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS100856545006010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPQSystem, simulation, radiation therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-12
Device Publish Date2020-06-04

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