# K052345: Advantage Sim MD

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 14, 2005 after 19 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945512 (1995). 15 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021780: Advantage Sim 6.0, General Electric Medical Systems (2002) Summary page 1.
- K032915: Advantage 4D Option, Ge Medical Systems, LLC (2003) Summary page 1.
- K010336: Advantage Windows CT/Pet Fusion, Ge Medical Systems, Inc. (2001) Summary page 1.
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 2.

## Most influential descendants
- K061671: Syngo Trued, Model VC10A (2006), 11 descendants of its own
- K071241: LMS-Liver (2007), 9 descendants of its own
- K132045: Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options (2013), 8 descendants of its own
- K121213: Vitreaadvanced (2012), 8 descendants of its own
- K132944: Advantagesim MD MR Pelvic Organ at Risk Segmentation (2014), 7 descendants of its own

## Recalls of this device
- May 24, 2012 · Class II · Z-0754-2013: It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simulta
- 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
- Feb 2, 2009 · Not classified · Z-1718-2009: It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultane

## Indications for use
AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beamn radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user to define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatment fields are displayed on transverse images, on reformatted sagittal, coronal or obligue images, on 3 D views created from the images, oron 2 beam eye’s view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.

Source page: https://510kreport.com/device/K052345
Methodology: https://510kreport.com/methodology