Hot Wire Cutter

Primary DI
B365530460
Brand
Hot Wire Cutter
Company
Aktina Corp.
Model
53-046
Published
2021-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K973953000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973953000AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEMAktina Medical Physics Corp.1998-01-14IXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B365530460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy beam block production hot-wireA mains electricity (AC-powered) device designed with a thin electrically-heated wire (hot-wire) that is used in the manual production of radiation therapy beam blocks (custom-made radiation collimators) which are used to configure a patient specific radiation field. The hot-wire is used to cut out the required patterns (the moulds) in a special Styrofoam material, e.g., Styrodur that will become templates used in the casting of a beam block(s). These moulds are configured from precise modelling data of the area to be treated for each individual patient thereby enabling production of exact beam blocks that control the treatment area during the radiotherapy treatment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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