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8 Ultrasound System Page 69
22. ACOUSTIC INFORMATION
22.1. Acoustic Output Summary Table
Description
of Probe
Operating
Mode
spta.X
statistically
determined
FDA I
spta.3
Published
Values
statistically
determined
FDA MI Published
Values
Linear 32mm
Probe
B 10.1 mW/cm
2
< 720 mW/cm
2
Cardiac
< 430 mW/cm
2
Fetal Imaging & Other**
2
0.649
< 1.9
Cardiac
< 1.9
Fetal Imaging & Other**
20mm Linear
Cue™ Needle
Tracking
System Probe
B 11.1 mW/cm
2
< 720 mW/cm
2
Cardiac
< 430 mW/cm
2
Fetal Imaging & Other**
2
0.58
< 1.9
Cardiac
< 1.9
Fetal Imaging & Other**
Pinpoint™ GT
20mm Linear
Probe
B 22.0 mW/cm
2
< 720 mW/cm
2
Cardiac
< 430 mW/cm
2
Fetal Imaging & Other**
2
0.871
< 1.9
Cardiac
< 1.9
Fetal Imaging & Other**
** Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonate Cephalic, Adult Cephalic.