Recognized standard
UD 2-2004 (R2009)
FDA recognition 12-105 · NEMA · Radiology
Key facts
| Recognition number | 12-105 |
|---|---|
| Designation | UD 2-2004 (R2009) |
| Title | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | This 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: