# K991553: Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7000TS W/Fluoro Option

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Jun 8, 1999 after 36 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: 2 generations back to K955255 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980837: Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7000TS, Shimadzu Medical Systems (1998) Summary page 2.

## Most influential descendants
- K994431: Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800 Series (2000), 0 descendants of its own

## Indications for use
This device is intended to be used in the examination of the whole body. 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/K991553
Methodology: https://510kreport.com/methodology