DEVICE: Electron Beam Shaping Full System, Siemens 95 cm, Full System (B365524850)

Device Identifier (DI) Information

Electron Beam Shaping Full System, Siemens 95 cm, Full System
52-485
In Commercial Distribution

Aktina Corp.
B365524850
HIBCC

1
787178920 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Radiation therapy beam block production plate A dedicated device, a dish, used for the manual production of beam blocks which serve to configure a radiation field. This device is used in the production of radiotherapy blocks to cool down the melted metal, e.g., Rose's metal [consisting of lead (Pb), tin (Sn) and bismuth] when this has been poured into the moulds. It may also have the function of vibrating the metal during the cooling process to ensure equal distribution of the metal throughout the mould.
Radiation therapy beam block production hot-wire A 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.
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FDA Product Code

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Product Code Product Code Name
IXI Block, Beam-Shaping, Radiation Therapy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K973953 000
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5b67828b-2460-48d0-9ca9-73da0a34a38f
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Yes
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Yes
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Customer Contact

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No Customer Contact currently defined
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