P35
In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a
report prepared by its Bioeffects Committee ("Bioeffects Considerations for the Safety
of Diagnostic Ultrasound." Journal of Ultrasound in Medicine, Vol. 7, No. 9 Supplement,
September 1988), sometimes referred to as the Stowe Report, which reviewed
available data on possible effects of ultrasound exposure. Another report, “Bioeffects
and Safety of Diagnostic Ultrasound,” dated January 28, 1993, provides more-current
information. The acoustic output for this system has been measured and calculated in
accordance with the “Acoustic Output Measurement Standard for Diagnostic
Ultrasound Equipment” (Revision 3, AIUM, NEMA, 2004), the “Standard for Real-Time
Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment” (Revision 2, AIUM, NEMA, 2004), and the September 2008 FDA document
"Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers."
