Recognized standard

4090 Third eidition 2001-08-15

FDA recognition 12-137 · ISO · Radiology

Key facts

Recognition number 12-137
Designation 4090 Third eidition 2001-08-15
Title Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications
Standards developer International Organization for Standardization
Specialty area Radiology
Date of entry Mar 31, 2006
Device classes Class 1, Class 2
Scope (excerpt) 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…

At a glance

  • 10–99 Product codes
  • 1–9 FDA guidance documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-recognized consensus standards

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date:

Browse all FDA-recognized consensus standards