Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-250: IEC 60601-2-44 Edition 3.0 2012-08, Amendment 1 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. (Radiology)
Date of Standard: 2012. |
| 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 Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
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| Devices Affected: |
| Computer Tomography Systems |
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| Processes Affected: |
| 510(k), PMA, IDE, Compliance |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete standard including annexes with the following exception:
Sub-clause 203.108 Dosimetry PHANTOM
Transition:
FDA recognition of IEC 60601-2-44 (2002-11) is hereby superseded by recognition of IEC 60601-2-44 Edition 3.0 2009-02 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. FDA will accept declaration of conformity, in support of premarket submissions, to IEC 60601-2-44 (2002-11) until June 30, 2013. After this transitional period, declaration of conformity to Ed. 2.1:2002-11 of this standard will not be accepted. |
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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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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.2050 |
Lung Computed Tomography System, Computer-Aided Detection |
Class 2 |
OEB |
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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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