Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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014
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Date of Entry 03/31/2006
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FR Recognition Number
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12-137
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Standard | |
ISO 4090 Third eidition 2001-08-15 Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications |
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Scope/AbstractThis International Standard specifies the nominal s, aim dimensions with tolerances, weights, and certain tests for medical radiographic cassettes, screens, and films. It includes medical hard-copy imaging films in the form of sheets, such as laser films and video.
This International Standard also includes information regarding the appropriate marking of these products, and special attention is given to cassettes/screens/films used for mammography.
This International Standard does not include films in roll format (see informative annex A). |
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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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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§892.1840 |
Film, Radiographic
|
Class 1
|
IWZ
|
§892.1840 |
Media, Reusable Image
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Class 1
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LQA
|
§892.1850 |
Cassette, Radiographic Film
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Class 2
|
IXA
|
§892.1860 |
Changer, Radiographic Film/Cassette
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Class 2
|
KPX
|
§892.1900 |
Controller, Temperature, Radiographic
|
Class 2
|
EGT
|
§892.1900 |
Dryer, Film, Radiographic
|
Class 2
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EGW
|
§892.1900 |
Processor, Radiographic-Film, Automatic, Dental
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Class 2
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EGY
|
§892.1900 |
Processor, Radiographic-Film, Automatic
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Class 2
|
IXW
|
§892.1900 |
Processor, Cine Film
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Class 2
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IXX
|
§892.1910 |
Grid, Radiographic
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Class 1
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IXJ
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§892.1960 |
Screen, Intensifying, Radiographic
|
Class 1
|
EAM
|
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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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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. |