# K982583: Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TXL

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Corp.
- Decided: Oct 5, 1998 after 73 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
This device is intended to be used in X-ray CT scanning on whole body. This device is operated and used by Physicians and X-ray technologist. The object of this device Is total patient population. As mentioned at “ Intended Use “ in this clearance letter, the intended use of the SCT-6800TXL is as same as that of predicate device SCT- 7000TX ( K955255) and there Is no additional indication.

Source page: https://510kreport.com/device/K982583
Methodology: https://510kreport.com/methodology