# K033874: Myolight

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems F.I. Haifa
- Decided: Dec 30, 2003 after 15 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: 2 generations back to K013353 (2002). 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)
- K021823: Cardiospect D90/Cardio Cam, Nuclear Cardiology Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K070589: C! (2007), 0 descendants of its own

## Indications for use
The intended use of the MyoLIGHT system is to perform Nuclear imaging procedures for detection and imaging of single photon radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

Source page: https://510kreport.com/device/K033874
Methodology: https://510kreport.com/methodology