Recognized standard
61689 Edition 4.0 2022-03
FDA recognition 12-376 · IEC · Radiology
Key facts
| Recognition number | 12-376 |
|---|---|
| Designation | 61689 Edition 4.0 2022-03 |
| Title | Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 26, 2025 |
| Scope (excerpt) | This document is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous (e.g. tone burst) wave ultrasound in the frequency range 0,5 MHz to 5 MHz. This document only relates to ultrasonic physiotherapy equipment… |
At a glance
- None 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: