# K012385: Hispeed X/I Smart Gantry Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Aug 10, 2001 after 14 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K091673: GE Lightspeed Act FP16 (2009), 0 descendants of its own

## Indications for use
The HiSpeed X/i Smart Gantry Option CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

Source page: https://510kreport.com/device/K012385
Methodology: https://510kreport.com/methodology