# K030420: Lightspeed 5.0 Computed Tomography System

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Mar 10, 2003 after 28 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013561 (2001). 1 ancestor in all.
112 later devices descend from it; 6 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)
- K013561: Lightspeed 4.0 CT Scanner System, GE Medical Systems (2001)

## Most influential descendants
- 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
- K081105: GE Lightspeed CT750 HD (Lightspeed 8.0) (2008), 35 descendants of its own

## Recalls of this device
- Feb 10, 2016 · Class II · Z-1053-2016: 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.
- 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 21, 2006 · Not classified · Z-0804-2007: Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

## Indications for use
The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications.

Source page: https://510kreport.com/device/K030420
Methodology: https://510kreport.com/methodology