Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-221: IEC 61223-3-4 First edition 2000-03, Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray. (Radiology)
Date of Standard: 2000. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | |
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| (2) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), PMA, Device Evaluation, Radiological Health Regulations |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.1800 |
System,X-Ray,Extraoral Source,Digital |
Class 2 |
MUH |
| §872.1800 |
Unit, X-Ray, Extraoral With Timer |
Class 2 |
EHD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.1810 |
Unit, X-Ray, Intraoral |
Class 2 |
EAP |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contacts: |
| William Jung |
| FDA/CDRH/OCER |
| 10903 New Hampshire Avenue Building 66, Room G238 |
| Silver Spring MD 20993 |
| 301/796-6228 |
| Email: william.jung@fda.hhs.gov |
|
| Michael Mendelson |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2548 |
| Silver Spring MD 20993 |
| 301/796-6280 |
| Email: michael.mendelson@fda.hhs.gov |
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