# K022794: E-Speed Ebt Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Imatron
- Decided: Oct 11, 2002 after 49 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
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.

Source page: https://510kreport.com/device/K022794
Methodology: https://510kreport.com/methodology