# K052855: Starspeed Series CT Scanner Systems

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Oct 28, 2005 after 17 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). 4 ancestors in all.
17 later devices descend from it; 1 cites 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)
- K030420: Lightspeed 5.0 Computed Tomography System, GE Medical Systems (2003) Summary page 2.
- K013561: Lightspeed 4.0 CT Scanner System, GE Medical Systems (2001) Summary page 2.
- K002978: Ligthspeed 3.0 CT Scanner System, GE Medical Systems (2000) Summary page 2.
- K000300: Lightspeed 2.0CT Scanner System, Ge Medical Systems, Inc. (2000) Summary page 2.

## Most influential descendants
- K082816: GE Brightspeed Delight CT Scanner System (2008), 16 descendants of its own
- 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

## Recalls of this device
- Nov 5, 2024 · Class II · Z-0614-2025: GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly
- May 24, 2018 · Class II · Z-2587-2018: 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).
- 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.
- 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 StarSpeed Series CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

Source page: https://510kreport.com/device/K052855
Methodology: https://510kreport.com/methodology