# K180318: PET Digital Gating

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Apr 11, 2018 after 65 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K161574: Discovery MI, Ge Medical Systems, LLC (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
PET Digital Gating generates a respiratory signal which can be used to automate motion correction of PET images with respiratory motion. Images that are motion-corrected using PET Digital Gating are intended to aid physicians in: detection; localization; evaluation; diagnosis; staging; restaging; monitoring; and/or follow up of disease, abnormality, and/or function; therapy planning, monitoring, and guidance; radiotherapy treatment planning; and for Nuclear Medicine interventional procedures. PET Digital Gating may be used with PET radiopharmaceuticals approved by the regulatory authority in the country of use, in patients of all ages, with a wide range of sizes, body habitus, and extent/type of disease. Areas of the body most impacted by respiratory motion are the chest, abdomen, and pelvis. Disease types in which respiratory motion may have a significant impact, if uncorrected, include: -Lung Cancer (e.g. Small Cell and Non-Small Cell); -Liver Cancer; -Colorectal Cancer; -Lymphoma (e.g. Hodgkin’s and Non-Hodgkin’s); -Cancers that have metastasized to the liver; -Cancers in the Thorax; and -Heart Disease

Source page: https://510kreport.com/device/K180318
Methodology: https://510kreport.com/methodology