• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 014 Date of Recognition 03/31/2006 
FR Recognition Number 12-137
Standard
ISO 4090 Third eidition 2001-08-15
Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications
Scope/Abstract
This 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).

Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§892.1960 Screen, Intensifying, Radiographic Class 1 EAM
§892.1910 Grid, Radiographic Class 1 IXJ
§892.1900 Controller, Temperature, Radiographic Class 2 EGT
§892.1900 Dryer, Film, Radiographic Class 2 EGW
§892.1900 Processor, Cine Film Class 2 IXX
§892.1900 Processor, Radiographic-Film, Automatic Class 2 IXW
§892.1900 Processor, Radiographic-Film, Automatic, Dental Class 2 EGY
§892.1860 Changer, Radiographic Film/Cassette Class 2 KPX
§892.1850 Cassette, Radiographic Film Class 2 IXA
§892.1840 Film, Radiographic Class 1 IWZ
§892.1840 Media, Reusable Image Class 1 LQA
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Radiology
-
-