# K192956: Auto Positioning

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hangwei Medical Systems Co., Ltd.
- Decided: Jan 16, 2020 after 87 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
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
- K131576: Optima CT660, Ge Medical Systems, LLC (2013). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Auto Positioning feature provides an alternate, streamlined and efficient workflow and performs quality and safety checks for the CT technologist in setting up CT examinations up to the initiation of the first scout scan. Auto Positioning acquires 3D spatial information of the individual patient on the table and combines it with information from the selected protocol to automatically calculate and visually display the scout’s start and end locations. Concurrently it checks for proper patient orientation, determines the table height for optimum patient centering, and checks for potential contact between the patient and the gantry. Upon acceptance by the technologist the patient is automatically moved to the correct scout start location. Use of Auto Positioning is intended to provide consistent patient positioning for optimal image quality and automatic exposure control.

Source page: https://510kreport.com/device/K192956
Methodology: https://510kreport.com/methodology