# K973168: Smartview Options for Hispeed CT/I

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 21, 1997 after 88 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: 2 generations back to K940606 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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.
- K964746: Hispeed CT/I with Performix Tube and Warp Scan Option, GE Medical Systems (1997) Summary page 1.

## Most influential descendants
- K153429: SmartView 3D Option (2016), 0 descendants of its own

## Indications for use
The SmartView Option for HiSpeed CT/i is indicated for head and whole body x-ray computed tomography applications. The SmartView Option is a “real time” reconstruction with a display latency less than one second. An in-room monitor provides an image display with 6 frame/sec display of ninety, 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.

Source page: https://510kreport.com/device/K973168
Methodology: https://510kreport.com/methodology