# K972879: Ultrafast CT Scanner; Ebt CT Scanner, Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Imatron, Inc.
- Decided: Oct 15, 1997 after 71 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
Longest line of descent: 1 generation back to K913352 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913352: C-150 Ultrafast CT Scanner, Imatron, Inc. (1991) Summary page 1.

## Indications for use
The intended use of the device here in question, i.e., the Imatron Ultrafast CT Scanner, remains unchanged from the intended use of prior predicate Imatron and other scanners. The Imatron Ultrafast CT Scanner is designed -- as are all similar devices -- to produce cross sectional images (i.e., thin slices) of the human anatomy. In this instance, such images are produced via helical (i.e., continuous volume or dynamic) or stationary (i.e., static) scanning. Imatron’s device is -- as are some of the predicate devices -- also intended 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.

Source page: https://510kreport.com/device/K972879
Methodology: https://510kreport.com/methodology