# K980169: Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of Systems

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Apr 13, 1998 after 87 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 3 cite it directly.
0 of 36 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 its predicate without a number.
- (no number) currently marketed head and whole body x-ray computed tomography systems: named in the summary without a submission 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

## Recalls of this device
- Dec 1, 2008 · Not classified · Z-2224-2009: During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requiremen
- Oct 21, 2004 · Not classified · Z-0269-05: The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of 

## Indications for use
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems are indicated for head and whole body x-ray computed tomography applications.

Source page: https://510kreport.com/device/K980169
Methodology: https://510kreport.com/methodology