E-Speed Ebt Scanner System

The intended use of the proposed GE Imatron e-Speed EBT Scanner System remains unchanged from the intended uses of prior predicate Imatron devices and other scanners. The e-Speed is designed - as are all predicate devices - to produce cross sectional images of the entire human anatomy.

Specifically, the e-Speed is intended:

1. to permit radiologic visualization of the heart, blood vessels, or lymphatic system, during or after injection of a contrast medium;

2. to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles;

3. to permit the data from certain three dimensional images to also be presented in time-sequenced or cine fashion;

4. to permit the data from three dimensional images to be viewed from a point of view moving inside the tissue, called "fly-through" mode for colons, blood vessels, or airways;

5. to be used for clinical situations requiring determination of specific quantitative information, such as the determination of calcium or other materials in bone, tumors, or organs;

6. to be used by the physician as an aid in the diagnosis of lung pathology;

7. for real-time motion studies, vascular and tissue'blood flow analysis, and full three-dimensional volume imaging.

The e-Speed will make use of previously cleared workstation software products and software applications.

Finally, such system is intended to be used in a manner consistent with those devices already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.