# K043381: Infinia Lightspeed

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems F.I. Haifa
- Decided: Dec 23, 2004 after 14 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K952674 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022960: GE Quasar Nuclear Medicine System, Ge Medical Systems F.I. Haifa (2002) Summary page 1.
- K030420: Lightspeed 5.0 Computed Tomography System, GE Medical Systems (2003) Summary page 1.
- K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera, Ge Medical Systems F.I. Haifa (1999) Summary page 1.

## Most influential descendants
- K083504: GE Discovery NM/CT 570C (2008), 0 descendants of its own

## Indications for use
The intended use of the "Infinia LightSpeed" system is to perform: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications. General Head & Body computed tomography (CT) applications. Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation correction imaging as well as functional and anatomical mapping imaging (registration and fusion).

Source page: https://510kreport.com/device/K043381
Methodology: https://510kreport.com/methodology