# K963896: Mobile CT Prospeed Family

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Dec 18, 1996 after 82 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: 1 generation back to K913485 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913485: CT Sytec 8000, General Electric Co. (1992) Summary page 1.
- K944013: CT Prospeed Family, GE Medical Systems (1995) Summary page 1.

## Indications for use
The Mobile CT ProSpeed is indicated for head and whole body x-ray computed tomography applications to be mounted in a trailer. The Mobile CT ProSpeed has the same indications for use as the CT ProSpeed Plus (formerly known as CT Sytec 8000 K913485) and CT ProSpeed Family with HiLight Detector K944013.

Source page: https://510kreport.com/device/K963896
Methodology: https://510kreport.com/methodology