User's Manual Part 2
Table Of Contents
Appendix
Acoustic output Reporting for Track 3
1
Appendix
Acoustic output Reporting for Track 3
Qisda Corporation follows Track 3 of the FDA’s information for
manufacturers seeking marketing clearance of diagnostic ultrasound
systems and transducers. Track 3 does not require evaluation of
acoustic output on an application-specific basis, but the global maximum
derated ISPTA must not exceed 720 mW/cm2 and the global maximum
MI must not exceed 1.9.
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