# K040372: Lightspeed 7.0 CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Mar 1, 2004 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
Longest line of descent: 2 generations back to K013561 (2001). 2 ancestors in all.
86 later devices descend from it; 4 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030420: Lightspeed 5.0 Computed Tomography System, GE Medical Systems (2003) Summary page 1.

## Most influential descendants
- 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
- K113342: Somatom Definition Flash (2011), 32 descendants of its own

## Recalls of this device
- May 19, 2017 · Class II · Z-2183-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 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-0803-2007: Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- Dec 21, 2006 · Not classified · Z-0802-2007: Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- Dec 8, 2006 · Not classified · Z-0507-2007: When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the t

## Indications for use
The LightSpeed 7.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

Source page: https://510kreport.com/device/K040372
Methodology: https://510kreport.com/methodology