Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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12-59
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Standard | |
IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics |
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Scope/AbstractSpecifies type tests to be performed by the manufacturer at the design and construction stages of a radiotherapy simulator but does not specify site tests to be performed after installation at the user's site. The accompanying technical report IEC 61170, however, does suggest that many of the test procedures are appropriate for site tests. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§892.5840 |
Radiation therapy simulation system.
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |