# K151372: Low Dose CT Lung Cancer Screening Option for Qualified GE Systems

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Aug 14, 2015 after 85 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013561 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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) Summary page 6.
- K040372: Lightspeed 7.0 CT Scanner System, Ge Medical Systems, LLC (2004) Summary page 6.

## Indications for use
The Low Dose CT (LDCT) Lung Cancer Screening Option (LCS) for Qualified GE Systems is indicated for using low dose CT for lung cancer screening. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Source page: https://510kreport.com/device/K151372
Methodology: https://510kreport.com/methodology