# K964746: Hispeed CT/I with Performix Tube and Warp Scan Option

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jan 24, 1997 after 59 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). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940606: Hispeed Advantage II, GE Medical Systems (1994) Summary page 1.

## Most influential descendants
- K973168: Smartview Options for Hispeed CT/I (1997), 1 descendant of its own
- K153429: SmartView 3D Option (2016), 0 descendants of its own
- K012238: Doseright (2001), 0 descendants of its own

## Indications for use
HiSpeed CT/i with Performix Tube and Warp Scan Option is intended to provide 0.8 second 360-degree helical or axial scans as well as increase the maximum tube heat capacity and provides additional mA settings over our existing system.

Source page: https://510kreport.com/device/K964746
Methodology: https://510kreport.com/methodology