# K961055: CT Prospeed CT/I

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jun 17, 1996 after 91 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 K940606 (1994). 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)
- K944013: CT Prospeed Family, GE Medical Systems (1995) Summary page 1.
- K940606: Hispeed Advantage II, GE Medical Systems (1994) Summary page 1.

## Indications for use
The CT ProSpeed CT/i is indicated for head and whole body x-ray computed tomography applications. It provides axial, helical and scout imaging.

Source page: https://510kreport.com/device/K961055
Methodology: https://510kreport.com/methodology