Recognized Consensus Standards

Recognition List Number: 018 Publication Date: 09/12/2007

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-145: IEC 61674(1997)(2002), Amendment 1, Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging. (Radiology)

Date of Standard: 1997.

Address of Standards Organization:

International Electrotechnical Commission (IEC)

3, Rue de Varembe'

PO Box 131

CH-1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Dosimeters used in X-ray Diagnostic Imaging

Processes Affected:

510(k), PMA, IDE, HDE

Type of Standard:

International, Vertical

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§892.5050	Accessory - Film Dosimetry System	Class 2	MWW

Regulation Number	Device Name	Device Class	Product Code
§892.5650	System, Applicator, Radionuclide, Manual	Class 1	IWJ

Regulation Number	Device Name	Device Class	Product Code
§892.5700	System, Applicator, Radionuclide, Remote-Controlled	Class 2	JAQ

Regulation Number	Device Name	Device Class	Product Code
§892.5750	Device, Beam Limiting, Teletherapy, Radionuclide	Class 2	IWD
§892.5750	System, Radiation Therapy, Radionuclide	Class 2	IWB

Regulation Number	Device Name	Device Class	Product Code
§892.5840	System, Simulation, Radiation Therapy	Class 2	KPQ

Regulation Number	Device Name	Device Class	Product Code
§892.5900	System, Therapeutic, X-Ray	Class 2	JAD

Regulation Number	Device Name	Device Class	Product Code
§892.5930	Assembly, Tube Housing, X-Ray, Therapeutic	Class 2	ITZ