FDA.reportPublic FDA data

Beam Block Tray, Lexan, No Coding, Solid

Primary DI
B36554000SL0
Brand
Beam Block Tray, Lexan, No Coding, Solid
Company
Aktina Corp.
Model
54-000-SL
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
IYEAccelerator, Linear, Medical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964840000BEAM BLOCK TRAYSAktina Medical Physics Corp.1997-02-11IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B36554000SL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual-aperture-control therapeutic x-ray system collimator, non-motorizedA non-motorized, x-ray beam-limiting and shaping device that is a component of a therapeutic x-ray system and that is adjusted manually. It is attached to the x-ray tube housing assembly and adjusts the size and shape of the x-ray beam to match the size and shape of a predefined target area or the shape of a x-ray cassette used for quality assurance purposes. It is used in radiation therapy applications to limit the effects of scattered radiation and to provide patient protection by limiting or eliminating exposure to non-target body areas during treatment. This device is specifically designed for use with an x-ray simulation or therapeutic x-ray system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787178920
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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B365601900Belly Compression Arch Kit60-1902016-09-24
B365603100Respiratory Belt with Bladder, Small60-3102016-09-28
B365603110Respiratory Belt with Bladder, Medium60-3112016-09-28
B365603120Respiratory Belt with Bladder, Large60-3122016-09-28
B365503710Transport Cart, SRS Cones50-3712021-05-21
B365503720Bar Code Reader Kit50-3722021-05-21
B365503750Film Holder50-3752021-05-21
B365503022100Circular Small Field Cone Insert, Elekta, 21mm50-302-2102016-10-04
B365503022200Circular Small Field Cone Insert, Elekta, 22mm50-302-2202016-10-04
B365503022300Circular Small Field Cone Insert, Elekta, 23mm50-302-2302016-10-04
B365503022400Circular Small Field Cone Insert, Elekta, 24mm50-302-2402016-10-04
B365503022500Circular Small Field Cone Insert, Elekta, 25mm50-302-2502016-10-04
B365503022600Circular Small Field Cone Insert, Elekta, 26mm50-302-2602016-10-04
B365503022700Circular Small Field Cone Insert, Elekta, 27mm50-302-2702016-10-04
B365503022800Circular Small Field Cone Insert, Elekta, 28mm50-302-2802016-10-04
B365503022900Circular Small Field Cone Insert, Elekta, 29mm50-302-2902016-10-04
B365503023000Circular Small Field Cone Insert, Elekta, 30mm50-302-3002016-10-04

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08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
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