# K032915: Advantage 4D Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Oct 30, 2003 after 38 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
Longest line of descent: 5 generations back to K945512 (1995). 7 ancestors in all.
216 later devices descend from it; 4 cite it directly.
1 of 224 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022919: Smart Breath Respiratory Compensation Option, GE Medical Systems (2002) Summary page 2.
- K021780: Advantage Sim 6.0, General Electric Medical Systems (2002) Summary page 2.

## Most influential descendants
- K091373: Syngo Trued (2009), 200 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K093621: Syngo.Pet&CT Oncology (2010), 54 descendants of its own

## Indications for use
Advantage 4D is a non-invasive software / hardware option that can be used to provide and display CT images of all phases of a breathing cycle for the evaluation of respiration-induced motion. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and group images by the phase selected. Advantage 4D can also be used for target or treatment volume (DICOM Radiation Therapy Structure Sets) verification

Source page: https://510kreport.com/device/K032915
Methodology: https://510kreport.com/methodology