# K012836: Modification to: Lightspeed Plus Mobile CT System

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Sep 7, 2001 after 15 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 K000300 (2000). 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)
- K000300: Lightspeed 2.0CT Scanner System, Ge Medical Systems, Inc. (2000) Summary page 1.

## Indications for use
The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray computed tomography applications. It can be operated in a mobile as well as a fixed site environment.

Source page: https://510kreport.com/device/K012836
Methodology: https://510kreport.com/methodology