# K013561: Lightspeed 4.0 CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 8, 2001 after 13 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
113 later devices descend from it; 3 cite it directly.
6 of 114 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
- K030420: Lightspeed 5.0 Computed Tomography System (2003), 112 descendants of its own
- K040372: Lightspeed 7.0 CT Scanner System (2004), 86 descendants of its own
- K061817: Lightspeed 7.1 CT Scanner System (2006), 45 descendants of its own
- K052216: Somatom Definition (2005), 38 descendants of its own
- K082220: Somatom Flash DS (2008), 36 descendants of its own

## Recalls of this device
- Feb 10, 2016 · Class II · Z-1048-2016: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
- Jul 17, 2015 · Class II · Z-2801-2015: Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
- Apr 22, 2015 · Class II · Z-1623-2015: GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely 
- Jul 25, 2011 · Class II · Z-1188-2013: Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly re
- Dec 8, 2003 · Not classified · Z-0306-04: Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.

## Indications for use
The LightSpeed 4 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

Source page: https://510kreport.com/device/K013561
Methodology: https://510kreport.com/methodology