Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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013
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Date of Entry 11/08/2005
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FR Recognition Number
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12-6
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Standard | |
IEC 60806 First edition 1984-01 Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis |
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Scope/AbstractThis standard is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES containing ROTATING ANODE X-RAY TUBES, for use in MEDICAL DIAGNOSTIC RADIOLOGY for techniques in which the X-RAY PATTERN will be received simultaneously in all points of the IMAGE RECEPTION AREA.
Unless otherwise specified, this standard is applicable to an X-RAY TUBE ASSEMBLY with a brand-new ROTATING ANODE X-RAY TUBE.
This standard does not apply to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES for special applications, when for example steeper variations of the AIR KERMA RATE or particular distributions are intended. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
FDA recognition of IEC 60806 First edition 1984-01 [Rec# 12-6] will be superseded by recognition of IEC 60806 Edition 2.0 2022-11 [Rec# 12-350]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-6] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 12-6] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§892.1760 |
Assembly, Tube Housing, X-Ray, Diagnostic
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Class 1
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ITY
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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. |