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Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Acoustic output table with Hitachi or FUJIFILM
Healthcare diagnostic ultrasound system
Acoustic output table for default settings when combined
with SSD-α10
Transducer Model: GF-UCT180
Acoustic Output
MI
TIS TIB
TIC
Maximum Value 0.36 0.11 0.21 0.18
Operating mode Mflow B/Bflow PWD B/Bflow
Operator
Controls
DVA% (%)70704870
Function Off Off Off Off
B/W Frequency Select (MHz) n/a 7.5 MHz n/a 7.5 MHz
B/W Focus n/a F9 n/a F9
B/W-Range (cm) 12.0 12.0 n/a 12.0
B/W Line Density n/a HIGH n/a HIGH
B/W Scan Area (%) n/a 100 n/a 100
Doppler Image Select n/a n/a STD n/a
Doppler Frequency Select (MHz) n/a n/a 6 MHz n/a
Doppler Focus n/a n/a F12 n/a
Doppler Velocity Range (cm/sec) n/a n/a 39.8 n/a
Color Image Select STD STD n/a STD
Color Doppler Frequency Select (MHz) 5 MHz 5 MHz n/a 5 MHz
Flow Focus F13 F13 n/a F13
Color Velocity Range (m/sec) 0.12 0.12 n/a 0.12
Color Line Density n/a LOW n/a LOW
Color Average n/a MID n/a MID
Flow Filter n/a #4 n/a #4
Flow Scan Area (%) n/a 49 n/a 49
Triplex Velocity Range n/a n/a n/a n/a
I
SPTA.3
(mW/cm
2
)
34 7.0 68 7.0
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