# K940606: Hispeed Advantage II

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Aug 23, 1994 after 194 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.
300 later devices descend from it; 5 cite it directly.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964747: Somatom Plus 4 CT Scanner (1997), 265 descendants of its own
- K982060: Volumax CT Imaging System (1998), 264 descendants of its own
- K012009: MX8000 Idt CT System (2001), 263 descendants of its own
- K033326: Philips Plus Computed Tomography System (2003), 214 descendants of its own
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner (2004), 147 descendants of its own

Source page: https://510kreport.com/device/K940606
Methodology: https://510kreport.com/methodology