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Intended to be used by or under the direction of a physician for 3-D clinical imaging in fetal applications. This is only to be used in conjunction with the 2D Ultrasound Imaging System marketed under the model name 'Sonata' or 'Telocin', labeled as 2D Ultrasound Imaging System manufactured by Tetrad Corporation.

Adds 3-D imaging capability to commercial 2-D ultrasound imaging system. Hardware includes Pentium IV 2.8 GHz, Frame Grabber digital via real time memory mapping in RAM, Video out via Sonata System, System keyboard control. Software features include Volume data acquisition w/frame grabbing of digital data b/w while scanning free-hand, Conditioning and transformation of the acquired data into a Cartesian volume, Surface rendering, Segmentation of structures from 3-D data.

The TETRAD Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

Technical specifications for the Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are as follows: | Specifications | Tetrad TC-<br>C52-ATP | Tetrad TC-<br>C84V-ATP | Tetrad TC-<br>C95-ATP | Tetrad TC-<br>CLA76-ATP | Tetrad TC-<br>L74-ATP | |---------------------|-----------------------|------------------------|-----------------------|-------------------------|-----------------------| | Center Frequency | 3.0 MHz<br>nominal | 6.0 MHz<br>nominal | 6.0 MHz<br>nominal | 4.0 MHz<br>nominal | 6.0 MHz<br>nominal | | Number of Elements | 128 | 128 | 128 | 128 | 128 | | Radius of Curvature | 40 mm | 12 mm | 8 mm | 76 mm | NA | | Bandwidth -6dB | 70% nominal | 60% nominal | 60% nominal | 50% nominal | >50% | | Elevation width | 15 mm | 5.5 mm | 4 mm | 15 mm | 5.5 mm | | Elevation Focus | 80 mm | 25 mm | 25 mm | 75 mm | 25 mm | | Lens material | silicone | Silicone | silicone | silicone | silicone | | Pitch | 0.3 mm | 0.2 mm | 0.15 mm | 0.6 mm | 0.2 mm |

The TETRAD Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

Technical specifications for the Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers are as follows: | Specifications | Tetrad TC-EC7-ACP | Tetrad TC-L5-ACP | Tetrad TC-L7-ACP | Tetrad TC-V4-ACP | |---|---|---|---|---| | Center Frequency | 7.0 MHz nominal | 6.0 MHz nominal | 8.0 MHz nominal | 4.0 MHz nominal | | Number of Elements | 128 | 128 | 128 | 128 | | Radius of Curvature | 12.5 | NA | NA | NA | | Bandwidth -6dB | 60% nominal | 60% nominal | 60% nominal | 58% nominal | | Elevation width | 6 mm | 4.1 mm | 4.1 mm | 15 mm | | Elevation Focus | 22 mm | 20 mm | 20 mm | 90 mm | | Lens material | Silicone | Silicone | Silicone | Silicone | | Pitch | 0.2 mm | 0.3 mm | 0.3 mm | 0.5 mm |