Recognition List Number: 022 Publication Date: 09/08/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-139: AIUM AOMS-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment . (Radiology)
Date of Standard: 2004. |
| Address of Standards Organization: |
| American Institute of Ultrasound in Medicine (AIUM) |
| 14750 Sweitzer Lane |
| Suite 100 |
| Laurel, MD 20707 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
|
|
| Devices Affected: |
| Non-fetal Ultrasound Monitor, Ultrasound pulsed Doppler Imaging System, Ultrasound Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer |
|
| Processes Affected: |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete Standard and any annexes
NOTE: NEMA UD2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3 -- is identical and may be used as an alternative to the AIUM standard. |
|
| 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 |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1560 |
System, Imaging, Pulsed Echo, Ultrasonic |
Class 2 |
IYO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1570 |
Media,Coupling,Ultrasound |
Class 2 |
MUI |
| §892.1570 |
Transducer, Ultrasonic, Diagnostic |
Class 2 |
ITX |
| |
|
| 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 |
|
|
