# K132045: Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hungary Kft
- Decided: Sep 4, 2013 after 64 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913770 (1991). 113 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052345: Advantage Sim MD, GE Healthcare (2005) Summary page 1.
- K130393: Mirada RTX, Mirada Medical, Ltd. (2013) Summary page 1.

## Most influential descendants
- K132944: Advantagesim MD MR Pelvic Organ at Risk Segmentation (2014), 7 descendants of its own
- K151233: Monaco (2015), 6 descendants of its own
- K183037: Monaco RTP System (2018), 5 descendants of its own
- K190178: Monaco RTP System (2019), 4 descendants of its own
- K202789: Monaco Rtp System (2021), 3 descendants of its own

## Indications for use
AdvantogeSini" MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dlosimetry planing. 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 volume may be assisted by additional CT. MIR or PET studies that have been co-registered ih the planning CT scan. Additionally ar & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined rangedo the respiratory cycle. The geometric parameters of a proposed treatment field are seiectea to allow non-dosirnetric. interactive optimization of feic ccverage. Dlefined anatomical structures and geometric treatments fields ore displayed or. transv'erse images. on reformatted sagittal. coronad or oblique images. on 3D views created from the images. or on a beam eye's view display With or withoui the display of defined structures wirn or wtlnit the display of digitally reconstructed radiograph.

Source page: https://510kreport.com/device/K132045
Methodology: https://510kreport.com/methodology