Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-241: IEC 62274 First Edition 2005-05, Medical electrical equipment - Safety of radiotherapy record and verify systems. (Radiology)
Date of Standard: 2005. |
| 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 IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
|
|
| Devices Affected: |
| Radiotherapy record and verify systems |
|
| Processes Affected: |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.5050 |
Accelerator, Linear, Medical |
Class 2 |
IYE |
| §892.5050 |
System, Radiation Therapy, Charged-Particle, Medical |
Class 2 |
LHN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.5750 |
System, Radiation Therapy, Radionuclide |
Class 2 |
IWB |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.5900 |
System, Therapeutic, X-Ray |
Class 2 |
JAD |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Nancy Wersto |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room G320 |
| Silver Spring MD 20993 |
| 301/796-6548 |
| Email: nancy.wersto@fda.hhs.gov |
|
|
