# K980176: Hispeed QX/I CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Apr 13, 1998 after 83 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
No predicates in its family tree.
32 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K991716: Hispeed NX/I CT Scanner System (1999), 31 descendants of its own
- K042328: Somatom Spirit (2004), 30 descendants of its own
- K140912: Somatom Scope/Somatom Scope Power (2014), 29 descendants of its own
- K142955: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power (2015), 27 descendants of its own
- K161196: SOMATOM Drive (2016), 24 descendants of its own

## Indications for use
The HiSpeed QX/i CT Scanner System is intended for head and whole body x-ray computed tomography applications.

Source page: https://510kreport.com/device/K980176
Methodology: https://510kreport.com/methodology