• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 014 FR Publication Date: 03/31/2006 

Part B: Supplementary Information

Recognition Number 12-136: ISO 9236-1:2004, photography - sensitometry of screen/film systems for medical radiography - part 1: determination of sensitometric curve shape, speed and average gradient. (Radiology)

Date of Standard: 2004. 
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:
X-Ray Film and Processing Equipment
Processes Affected:
510(k)
Type of Standard:
 Vertical, International
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
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
-
-