| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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028
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Date of Entry 03/16/2012
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|
FR Recognition Number
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12-105
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| Standard | |
NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
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Scope/AbstractThis standard covers all active ultrasound apparatus designed for medical diagnostic use, including ultrasonic echo ranging devices (both manual and automatically scanned), through-transmission devices, Doppler echo equipment, and combinations thereof.
This document establishes measurement standards for acoustic output quantities of ultrasonic diagnostic equipment.
Measurements of acoustic output quantities are to be performed in water. However, in order to provide values more typical of what might occur within tissue, derated values of output quantities will be required in addition to the in-water values. To provide an example, detailed derating procedures and requirements are discussed in this standard for a specific model; this is a 0.3 dB/cm-MHz uniform attenuation model, and will be notationally designated by the subscript ".3," i.e., ISPPA.3.
It is anticipated that in the future, different derating factors will be necessary to better represent different applications. The standard provides for the implementation of different derating schemes by the manufacturer, provided that the implementation of that scheme is described. |
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| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §892.1540 |
Monitor, Ultrasonic, Nonfetal
|
Class 2
|
JAF
|
| §892.1550 |
System, Imaging, Pulsed Doppler, Ultrasonic
|
Class 2
|
IYN
|
| §892.1560 |
System, Imaging, Pulsed Echo, Ultrasonic
|
Class 2
|
IYO
|
| §892.1570 |
Transducer, Ultrasonic, Diagnostic
|
Class 2
|
ITX
|
| §892.1570 |
Media, Coupling, Ultrasound
|
Class 2
|
MUI
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Document issued on: September 9, 2008
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
