# K021780: Advantage Sim 6.0

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems
- Decided: Jul 29, 2002 after 60 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- 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 K951830 (1995). 1 ancestor in all.
217 later devices descend from it; 3 cite it directly.
1 of 219 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951830: Advantage Sim, General Electric Co. (1995) Summary page 1.

## Most influential descendants
- K032915: Advantage 4D Option (2003), 216 descendants of its own
- 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

## Recalls of this device
- Nov 24, 2010 · Not classified · Z-1473-2011: GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combinati

## Indications for use
Advantage Sim 6.0 is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior io dosimetry plannin,o. Anatomical volumes can be defined in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and seometric treatments fields are displayed on transverse CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye‘s view display with or without the display of defined structures with or without the display of disjttaly reconstructed radiogaph.

Source page: https://510kreport.com/device/K021780
Methodology: https://510kreport.com/methodology