Recognized Consensus Standards

Recognition List Number: 021 Publication Date: 03/18/2009

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-190: IEC 61217 (2008), Radiotherapy equipment - Coordinates, movements, and scales Consolidated Edition 1.2. (Radiology)

Date of Standard: 2008.

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:

Radiation Therapy Systems

Processes Affected:

510(k), PMA, PDP, IDE, HDE

Type of Standard:

International, Vertical

Extent of Recognition:

Description of Coordinates, movements and scales

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§892.5050	Accelerator, Linear, Medical	Class 2	IYE
§892.5050	Accessory - Film Dosimetry System	Class 2	MWW
§892.5050	Betatron, Medical	Class 2	IYG
§892.5050	Cyclotron, Medical	Class 2	IWK
§892.5050	Dosimeter, Ionizing Radiation, Implanted	Class 2	NZT
§892.5050	Microtron, Medical	Class 2	JAE
§892.5050	Synchrotron, Medical	Class 2	IWM
§892.5050	System, Radiation Therapy, Charged-Particle, Medical	Class 2	LHN
§892.5050	System,Planning,Radiation Therapy Treatment	Class 2	MUJ

Regulation Number	Device Name	Device Class	Product Code
§892.5300	System, Radiation Therapy, Neutron, Medical	Class 2	IWL

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