# K082816: GE Brightspeed Delight CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Oct 8, 2008 after 13 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013561 (2001). 5 ancestors in all.
16 later devices descend from it; 2 cite it directly.
6 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052855: Starspeed Series CT Scanner Systems, GE Healthcare (2005) Summary page 2.

## Most influential descendants
- K093514: Discovery Model NM/CT 670 (2009), 13 descendants of its own
- K153402: Discovery NM/CT 670 CZT (2016), 6 descendants of its own
- K182484: VERITON CT whole body SPECT/CT system (2018), 3 descendants of its own
- K190457: VERITON CT whole body SPECT/CT system (2019), 2 descendants of its own
- K111445: Discovery NM 630 (2011), 2 descendants of its own

## Recalls of this device
- May 24, 2018 · Class II · Z-2586-2018: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- Apr 27, 2018 · Class II · Z-2873-2018: GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
- Apr 27, 2018 · Class II · Z-2872-2018: GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
- May 19, 2017 · Class II · Z-2188-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- May 19, 2017 · Class II · Z-2186-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- Oct 9, 2013 · Class II · Z-0840-2014: There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another 
- Jan 19, 2011 · Not classified · Z-2214-2011: GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain BrightSpeed systems (BrightSpeed Excel/Edge/Elite Sele
- Sep 3, 2010 · Not classified · Z-0369-2011: GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.
- Sep 3, 2010 · Not classified · Z-0368-2011: GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.

## Indications for use
The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

Source page: https://510kreport.com/device/K082816
Methodology: https://510kreport.com/methodology