FDA.reportPublic FDA data

.decimal Proton Shell and Lid Assembly

Primary DI
00851147007083
Brand
.decimal Proton Shell and Lid Assembly
Company
DECIMAL, INC.
Model
2.3
Device description
A reusable steel Shell & Lid (or material with similar attenuating properties) with a 2D hole cut from it which is where the custom Brass core is to be placed for treatment with a proton beam.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MUJSystem,Planning,Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132236000.DECIMAL PROTON APERTURE.Decimal, Inc.2013-10-16IXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851147007083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851147007083008511470070838511470070830851147007083

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
00851147007014.decimal Proton Range Compensator2.82016-09-24
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

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Primary DI, Brand, Company table
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