FDA.reportPublic FDA data

High-Definition 120 Multileaf Collimator

Primary DI
00899475002110
Brand
High-Definition 120 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
K071992000
K133240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071992000HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)Varian Medical Systems2007-08-15IYE
K133240000VARIAN MULTILEAF COLLIMATORVarian Medical Systems, Inc.2014-01-31IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899475002110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899475002110008994750021108994750021100899475002110

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856100006493Respiratory Gating for Scanners2.12026-06-05
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmGM11014100GM110141002026-06-02
00816389020191Applicator and Dilator for Proctoscope ø26 mmGM11014310GM110143102026-05-26
00816389020207Applicator and Dilator for Proctoscope ø30 mmGM11014410GM110144102026-05-26
00816389028098Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014110GM110141102026-05-26
00816389028104Proctoscope ø 26 mmGM11014120GM110141202026-05-26
00816389028111Dilator for Proctoscope ø 26 mmGM11014130GM110141302026-05-26
00816389028128Illumination Adapter for Proctoscope ø 26 mmGM11014150GM110141502026-05-26
00816389028135Fixation ScrewGM11014160GM110141602026-05-26
00816389028142MAASTRO Rectal Applicator Set, ø 30 mmGM11014200GM110142002026-05-26
00816389028159Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014210GM110142102026-05-26
00816389028166Proctoscope ø 30 mmGM11014220GM110142202026-05-26
00816389028173Dilator for Proctoscope ø 30 mmGM11014230GM110142302026-05-26
00816389028180Illumination Adapter for Proctoscope ø 30 mmGM11014250GM110142502026-05-26
00816389028999Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014170GM110141702026-05-26
00816389029002Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014270GM110142702026-05-26
00850800006074Vitesee5.0Vitesse 5.02024-11-01
00810563022032ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
00810563022049ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
00810563022056ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22