K Indications for use
Operator’s Manual K - 9
Transducer: SC5-1Ns
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General(Track 1
Only)
Specific (Track 1 & 3) B M PWD CWD Color
Doppler
Power
Doppler
Combine
d
(specify
)
Other (Specify)
Ophthalmic Ophthalmic
Fetal Imaging &
Other
Fetal N N N N N N Note 1, 2,3,5
Abdominal N N N N N N Note 1, 2,3,5,8
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric N N N N N N Note 1, 2,3,5
Small Organ (Specify**)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
N N N N N N Note 1, 2,3,5
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify***)
N N N N N N Note 1, 2,3,5
Urology N N N N N N Note 1, 2,3,5
Cardiac
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel Peripheral vessel N N N N N N Note 1, 2,3,5
N=new indication
:
P=previously cleared by FDA
;
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.
***Thoracic/Pleural - For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart 3D
Note 3: iScape View
Note 4: TDI
Note 5: Color M
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)
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