DEVICE: High Energy Beam Block Set (B365112900)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Manual-aperture-control therapeutic x-ray system collimator, non-motorized | A 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. |
FDA Product Code
[?]Product Code | Product Code Name |
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IXI | Block, Beam-Shaping, Radiation Therapy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9b00a8d8-94bb-444c-8d1b-3e9169af4d31
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined