Indications For Use I-1
Appendix I 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
****For detection of fluid and pleural motion/sliding
Note 1: Tissue Harmonic Imaging
Note 2: Smart 3D
Note 3: 4D (Real-time 3D)
Note 4: iScape View
Note 5: TDI
Note 7: Strain Elastography
Note 8: Contrast imaging (Contrast agent for LVO)
Note 9: V Flow
Note10: STE
Note11: STQ
Note12: Contrast imaging (Contrast agent for Liver)
Note: The system is not intended for central cardiovascular or central nervous system use.
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