# K091673: GE Lightspeed Act FP16

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Jun 24, 2009 after 15 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012385 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012385: Hispeed X/I Smart Gantry Option, Ge Medical Systems, Inc. (2001) Summary page 1.

## Recalls of this device
- May 19, 2017 · Class II · Z-2187-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

## Indications for use
The GE LightSpeed TM ACT FP16 is indicated for head and whole body X-ray computed tomography applications. GE LightSpeed TM ACT FP16 is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, cardiology, diagnostic and interventional procedures, and optionally, rotational imaging procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology and is not intended for mammography applications.

Source page: https://510kreport.com/device/K091673
Methodology: https://510kreport.com/methodology