Recognized standard
61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION
FDA recognition 12-312 · IEC · Radiology
Key facts
| Recognition number | 12-312 |
|---|---|
| Designation | 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION |
| Title | Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard describes methods of calibrating the spatial measurement facilities and point-spread function of ultrasonic imaging equipment in the ultrasonic frequency range 0,5 MHz to 15 MHz. This standard is relevant for ultrasonic scanners based on the pulse-echo principle of the… |
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: