Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-232: NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices. (Radiology)
Date of Standard: 2010. |
| Address of Standards Organization: |
| National Electrical Manufacturers Association (NEMA) |
| 1300 North 17th Street |
| Suite 1847 |
| Rosslyn, VA 22209 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
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| Devices Affected: |
| Magnetic Resonance Imaging Systems |
|
| Processes Affected: |
| 510(k), Methodology for Measurement of Device Characteristics |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1000 |
Coil, Magnetic Resonance, Specialty |
Class 2 |
MOS |
| §892.1000 |
System, Nuclear Magnetic Resonance Imaging |
Class 2 |
LNH |
| §892.1000 |
System, Nuclear Magnetic Resonance Spectroscopic |
Class 2 |
LNI |
| |
|
| Relevant Guidance: |
Guidance for Industry
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998 |
|
| FDA Technical Contact: |
| Sunder Rajan |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 1113 |
| Silver Spring MD 20993 |
| 301/796-4194 |
| Email: sunder.rajan@fda.hhs.gov |
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