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Acoustic Output Reporting Table – Track 3, FDA 510(k)
(Per transducer/mode that exceeds MI or TI value of 1.0)
Transducer model: CW2
Associated Acoustic Parameters
Index Label
Maximum Value
---
P
(MPa)
r.3
W
(mW)
o
min of [W
(z
), I
(z
)]
(mW)
.3
1
TA.3
1
z
(cm)
1
z
(cm)
bp
z
(cm)
sp
d
(z
)
(cm)
eq
sp
f
(MHz)
c
Dim. of A
X (cm)
aprt
Y (cm)
Other information
PD
(μsec)
PRF
(Hz)
P
@ PII max
(MPa)
r
d
@ PII max
(cm)
eq
Focal Length
FLx (cm)
FLy (cm)
I
@ MI max
(W/cm2)
pa.3
Operator Control
TX-Level
(dB)
Focus
(mm)
PRF
(Hz)
a
This Index is not relevant to this operating mode.
b
This transducer is not intended for transcranial or neonatal cephalic uses.
c
This formulation for TIS is less than that for an alternate formulation in this mode.
#
No data is provided for this operation condition since the maximum index value is not reported for the reason listed.
D - 6 0
Operating mode: Continuous Wave Doppler
MI
TIS
Scan
Non-scan
A
≤1
aprt
-
---
0.35
-
#
36.74
-
-
#
2.00
#
0.88
#
0.87
-
-
-
#
10.00
#
10.00
-
-
0
TIB
TIC
Non-scan
A
>1
aprt
#
1.02
0.93
5.30
36.69
#
#
#
1.20
0.20
#
2.00
2.00
#
0.88
0.88
#
0.87
0.87
0.20
0.54
#
10.00
#
10.00
0
0
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