# K970606: Computed Tomography X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Apr 4, 1997 after 45 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K974344: CT Scope (1998), 0 descendants of its own

## Indications for use
The CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options is indicated for head and whole body x-ray computed tomography applications. These options are modifications which can be added to the existing family of ProSpeed Systems. The options include Warp Scan Option which is intended to provide 0.8 second 360-degree helical or axial scans. Fluoro Scan Option is an almost “real time” reconstruction (Smart Recon) with a display latency of 0.8 to 1.6 seconds. An in-room monitor provides an image display with either a 3 frame/ sec or 6 frame/sec display of 90 one second rotation scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging. SmartPrep Option is a tool to aid in triggering a helical or axial series of scans after contrast is injected. It allows the operator to monitor contrast as it enhances. A series of images, acquired immediately after injection, is automatically displayed along with pre-selected regions of interest. A graph plots the increase in CT numbers. When the region of interest begins approaching peak enhancement the operator can see that happen on the graph and initiate the CT series.

Source page: https://510kreport.com/device/K970606
Methodology: https://510kreport.com/methodology