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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 014 FR Publication Date: 03/31/2006 

Part B: Supplementary Information

Recognition Number 12-137: ISO 4090:2001, photography - medical radiographic cassette/screens/films and hard-copy imaging films - dimensions and specifications. (Radiology)

Date of Standard: 2001. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Radiographic Film and Any Device that Uses or Contains Film (e.g. Cassettes)
Processes Affected:
510(k)
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1840 Film, Radiographic Class 1 IWZ
§892.1840 Media, Reusable Image Class 1 LQA
§892.1850 Cassette, Radiographic Film Class 2 IXA
§892.1860 Changer, Radiographic Film/Cassette Class 2 KPX
§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
§892.1910 Grid, Radiographic Class 1 IXJ
§892.1960 Screen, Intensifying, Radiographic Class 1 EAM
FDA Technical Contact:
 Robert Jennings
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 3102
  Silver Spring MD 20993
  301/796-2539
  email: robertj.jennings@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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