Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-140: AIUM RTD2-2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2. (Radiology)
Date of Standard: 2004. |
| Address of Standards Organization: |
| American Institute of Ultrasound in Medicine (AIUM) |
| 14750 Sweitzer Lane |
| Suite 100 |
| Laurel, MD 20707 |
| |
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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: |
| Non-fetal Ultrasound Monitor, Ultrasound pulsed Doppler Imaging System, Ultrasound Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer |
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| Processes Affected: |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete Standard and any annexes
NOTE: NEMA UD3-2004(R2009)Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2 -- is identical and may be used as an alternate to this AIUM standard. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1540 |
Monitor, Ultrasonic, Nonfetal |
Class 2 |
JAF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1550 |
System, Imaging, Pulsed Doppler, Ultrasonic |
Class 2 |
IYN |
| |
|
| Relevant Guidance: |
| Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Document issued on: September 9, 2008 |
|
| FDA Technical Contacts: |
| Gerald Harris |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 2104 |
| Silver Spring MD 20993 |
| 301/796-2508 |
| Email: gerald.harris@fda.hhs.gov |
|
| Lauren N. Hefner |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room G312 |
| Silver Spring MD 20993 |
| 301/796-6881 |
| Email: lauren.hefner@fda.hhs.gov |
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