Recognized Consensus Standards

Recognition List Number: 027 Publication Date: 08/02/2011

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-229: IEC PAS 61910-1 First Edition 2007-07, Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy. (Radiology)

Date of Standard: 2007.

Address of Standards Organization:

International Electrotechnical Commission (IEC)

3, Rue de Varembe'

PO Box 131

CH-1211 Geneva 20, 0

SWITZERLAND

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)

(2)	OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER)

(3)	OFFICE OF COMPLIANCE (OC)

Devices Affected:

Equipment for performing radiography and fluoroscopy; excluding equipment for performing: dental radiography and fluoroscopy, mammography, computed tomography

Processes Affected:

510(k), QSR

Type of Standard:

Horizontal, International

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§892.1650	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Class 2	MQB
§892.1650	System, X-Ray, Fluoroscopic, Image-Intensified	Class 2	JAA

Regulation Number	Device Name	Device Class	Product Code
§892.1700	Generator, High-Voltage, X-Ray, Diagnostic	Class 1	IZO

Regulation Number	Device Name	Device Class	Product Code
§892.1720	System, X-Ray, Mobile	Class 2	IZL