# K992740: Ebt Ultrafast CT Scanner System; Ultrafast CT Scanner System; C-100, C-150, C-150LXP or C-150XP Scanner Systems

- Pathway: 510(k) (Traditional)
- Applicant: Imatron, Inc.
- Decided: Nov 9, 1999 after 85 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 its predicate without a number.
- (no number) Imatron Ultrafast CT scanner system: named in the summary without a submission number

## Indications for use
The Imatron EBT scanner system — when used angiographically - is intended to combine the capabilities of both a CT and angiography system. When used for this purpose, the system is intended to perform Electron Beam Angiography, i.e., “EBA”. More specifically, the EBT system is intended: 1. 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; 2. to permit radiologic visualization during or after injection of a contrast medium; and 3. to permit the transmission data from certain three dimensional images to also be presented in time-sequenced or ciné fashion. Finally, such system is intended to be used consistent with those already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.

Source page: https://510kreport.com/device/K992740
Methodology: https://510kreport.com/methodology