# K132944: Advantagesim MD MR Pelvic Organ at Risk Segmentation

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hungary Kft
- Decided: Mar 14, 2014 after 176 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: 13 generations back to K913770 (1991). 149 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132045: Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options, Ge Hungary Kft (2013) Summary page 1.
- K111311: Segmentation Assistant for Prostate-Auto Contouring, Omisa Inc. (Segasist Technologies) (2011) Summary page 1.

## Most influential descendants
- 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
- K213787: Monaco RTP System (2022), 2 descendants of its own

## Indications for use
AdvantageSlm ' IMD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dlosimetry 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 or PEr studies that have been co-registered with the planning CTscan. Additionally, CT & PEr data from a respiratory tracked examination may be used to allow the user 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-dlosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3D views created from the images, or on a 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/K132944
Methodology: https://510kreport.com/methodology