# K994431: Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800 Series

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Mar 23, 2000 after 84 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: 3 generations back to K955255 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991553: Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7000TS W/Fluoro Option, Shimadzu Corp. (1999) Summary page 2.

## Indications for use
This device is intended to be used in the examination of the whole body. This device is used optionally in CT Fluoroscopy. This device is operated and used by Physicians and X-ray technologist. The object of this device is total patient populations.

Source page: https://510kreport.com/device/K994431
Methodology: https://510kreport.com/methodology