Recognized standard
61391-2 Edition 1.0 2010-01
FDA recognition 12-228 · IEC · Radiology
Key facts
| Recognition number | 12-228 |
|---|---|
| Designation | 61391-2 Edition 1.0 2010-01 |
| Title | Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 61391 defines terms and specifies methods for measuring the maximum depth of penetration and the local dynamic range of real-time ultrasound B-MODE scanners. The types of transducers used with these scanners include: - mechanical probes; - electronic phased arrays; - linear arrays… |
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: