# K973329: Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TX

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Oct 8, 1997 after 34 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 K955255 (1996). 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)
- K955255: Shimadzu Whole Body X-Ray CT Scanner SCT-7000TX, Shimadzu Medical Systems (1996) Summary page 2.

## Indications for use
The SCT-6800TX is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring, and can perform the spiral CT scanning besides conventional scanning. The SCT-6800TX is basically similar in design, composition and function to the SCT-7000TX (K955255). Therefore, the intended use of the SCT-6800TX is the same as that of the predicate device SCT-7000TX(K955255).

Source page: https://510kreport.com/device/K973329
Methodology: https://510kreport.com/methodology