Recognition List Number: 026 Publication Date: 02/28/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-226: IEC 61223-2-6 Second Edition 2006-11, Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment. (Radiology)
Date of Standard: 2006. |
| 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 COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER) | | DIVISION OF MAMMOGRAPHY QUALITY AND RADIATION PROGRAMS (DMQRP) |
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| (3) | OFFICE OF COMPLIANCE (OC) | | DIVISION OF ENFORCEMENT B (DOEB) |
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| Devices Affected: |
| Computed Tomography X-Ray Systems |
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| Processes Affected: |
| 510(k), PMA, IDE, Compliance |
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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 |
| §892.1750 |
System, X-Ray, Tomography, Computed |
Class 2 |
JAK |
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| Relevant Guidance: |
| Guidance for Industry, FDA Staff and Third Parties - Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography. Document issued on October 20, 2006. |
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| FDA Technical Contact: |
| Stanley H. Stern |
| FDA/CDRH/OCER |
| 10903 New Hampshire Avenue Building 66, Room 4538 |
| Silver Spring MD 20993 |
| 301/796-5894 |
| Email: stanley.stern@fda.hhs.gov |
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