.decimal Proton Range Compensator

Primary DI
00851147007014
Brand
.decimal Proton Range Compensator
Company
DECIMAL, INC.
Model
2.8
Device description
Custom manufactured solid Range Compensators for intensity modulation of external beam proton radiation therapy.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IXIBlock, Beam-Shaping, Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXIBlock, Beam-Shaping, Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071078000.DECIMAL RANGE COMPENSATOR.Decimal, Inc.2007-05-22IXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851147007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851147007014008511470070148511470070140851147007014

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy beam block materialA material designed for creating a custom-made beam block used to size, shape, or control depth of penetration of a beam of radiation delivered to a patient during radiation therapy treatments, to limit or eliminate exposure to non-target body areas. Beam block material is either: 1) a highly attenuating material, e.g., lead, cerrobend (Wood’s metal), or Rose's metal (aperture type); or 2) a material such as acrylic or wax that can be used to control the beam energy delivery depth. It can be cut or moulded into specific configurations to shape/define/attenuate the radiation beam, and is typically remelted for reuse after the patient treatment is considered finished.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
617041967
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851147007144.decimal Blocking TrayN/A2023-07-19
00851147007113Decimal3DN/A2022-12-01
00851147007137decimal Bolus (FlexiBol)N/A2022-12-01
00851147007120.decimal Astroid Planning App 3.x3.x2022-11-23
00851147007007.decimal Proton Aperture2.32016-09-23
00851147007021.decimal Electron Bolus1.02016-09-24
00851147007038.decimal Electron Aperture1.02016-09-24
00851147007045.decimal Photon Block1.32016-09-24
00851147007052.decimal Photon Compensator1.02016-09-24
00851147007069.decimal P.D5.12016-09-24
00851147007076.decimal Astroid Dosimetry App1.02016-09-24
00851147007083.decimal Proton Shell and Lid Assembly2.32016-09-24

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Primary DI, Brand, Company table
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05060191071215Apex™ELEKTA LIMITEDIXI2016-09-24
00851147007021.decimal Electron BolusDECIMAL, INC.IXI2016-09-24
00851147007038.decimal Electron ApertureDECIMAL, INC.IXI2016-09-24
00851147007045.decimal Photon BlockDECIMAL, INC.IXI2016-09-24
00851147007052.decimal Photon CompensatorDECIMAL, INC.IXI2016-09-24
00851147007007.decimal Proton ApertureDECIMAL, INC.IXI2016-09-23