Operator’s Manual J - 1
J Indications For Use
N=new indication ； P=previously cleared by FDA ； E=added under Appendix E
Additional comments：Combined modes--B+M、 PW+B、 Color + B、 Power + B、 PW
+Color+ B、 Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart 3D
Note 3:4D(Real-time 3D)
Note 4: iScape View
Note 5: TDI
Note 6: Color M
Note8: Strain Elastography
Note 9: Contrast imaging (Contrast agent for LVO)
Note 11: V Flow
Note12: STE
Note13: STQ
Note14: Contrast imaging (Contrast agent for Liver)
Transducer: N/A
Intended
Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
Mode of Operation
General(Tr
ack 1 Only)
Specific
(Track 1 & 3)
BM
PW
D
CW
D
Color
Doppl
er
Amplitu
de
Doppler
Combin
ed
(specify
)
Other (Specif
y)
Ophthalmic Ophthalmic
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