FDA.reportPublic FDA data

Millennium 120-leaf Multileaf Collimator

Primary DI
00899475002127
Brand
Millennium 120-leaf Multileaf Collimator
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
8.1
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133240000VARIAN MULTILEAF COLLIMATORVarian Medical Systems, Inc.2014-01-31IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899475002127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899475002127008994750021278994750021270899475002127

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-aperture-control accelerator system collimatorA motorized, radiation beam-limiting device that is a component of a therapeutic accelerator system and composed of highly-attenuating materials or alloys [e.g., lead (Pb), tungsten (W)] with jaw or leaf positioning functions that are computer-controlled. Mounted at the beam exit port, it is used to adjust the shape of the radiation beam to the body area targeted for treatment. It provides patient protection by limiting or eliminating radiation delivery to non-target body areas during treatment. A light localizer is typically included in the design of the device to indicate the location of the radiation beam and assist in the positioning of patients for treatment.

Regulatory Flags#

DUNS number
009120817
Device count
1
Serial number
true
Manufacturing date on label
true

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00810563020908TempProbe™ DeviceDP40-0015-213CRYO-55-F2022-02-18
00810563020915Prostate Procedure Probe PackDP35-0965-101CRYO-204-V2022-02-18
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008163890289062.4mm V-Probe™ CryoprobeDP35-0902-101CVA24002022-02-18

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