FDA.reportPublic FDA data

Proton Systems, LLC

Primary DI
00861206000375
Brand
Proton Systems, LLC
Company
PROTON SYSTEMS VIRGINIA LLC
Model
30x40 Brass 360 Aperture
Device description
Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is patient specific and for single use.
Published
2016-12-02
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
IYEAccelerator, Linear, Medical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121657000PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATORProton Systems2012-10-23IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861206000375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861206000375008612060003758612060003750861206000375

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
048148197
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861206000337Proton Systems, LLC 18cm Brass 360 Aperture 2016-12-02
00861206000344Proton Systems, LLC 18cm Wax Range Compensator2016-12-02
00861206000351Proton Systems, LLC25cm Brass 360 Apertrure2016-12-02
00861206000368Proton Systems, LLC25cm Wax Range Compensator2016-12-02
00861206000382Proton Systems, LLC 30x40 Wax Range Compensator2016-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
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08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
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08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
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08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
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08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.IYE2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.IYE2026-04-22
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08720168162908Handgrips HNS, set/2MACROMEDICS B.V.IYE2026-04-21
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