Recognized Consensus Standards

Recognition List Number: 014 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 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:

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

Regulation Number	Device Name	Device Class	Product Code
§892.1850	Cassette, Radiographic Film	Class 2	IXA

Regulation Number	Device Name	Device Class	Product Code
§892.1860	Changer, Radiographic Film/Cassette	Class 2	KPX

Regulation Number	Device Name	Device Class	Product Code
§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

Regulation Number	Device Name	Device Class	Product Code
§892.1910	Grid, Radiographic	Class 1	IXJ

Regulation Number	Device Name	Device Class	Product Code
§892.1960	Screen, Intensifying, Radiographic	Class 1	EAM