Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-225: NEMA XR 25, Computed Tomography Dose Check. (Radiology)
Date of Standard: 2010. |
| Address of Standards Organization: |
| National Electrical Manufacturers Association (NEMA) |
| 1300 North 17th Street |
| Suite 1847 |
| Rosslyn, VA 22209 |
| |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | |
|
| (2) | OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER) | | DIVISION OF MAMMOGRAPHY QUALITY AND RADIATION PROGRAMS (DMQRP) |
|
| (3) | OFFICE OF COMPLIANCE (OC) | | DIVISION OF ENFORCEMENT B (DOEB) |
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| Devices Affected: |
| Computed Tomography Imaging Devices or Systems |
|
| Processes Affected: |
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| Type of Standard: |
| Vertical, National |
| 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 |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Kish Chakrabarti |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room G308 |
| Silver Spring MD 20993 |
| 301/796-6539 |
| Email: kish.chakrabarti@fda.hhs.gov |
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