# K111311: Segmentation Assistant for Prostate-Auto Contouring

- Pathway: 510(k) (Traditional)
- Applicant: Omisa Inc. (Segasist Technologies)
- Decided: Oct 17, 2011 after 160 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954678 (1996). 53 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090833: Segment, Medviso (2009) Summary page 1.
- K080799: Atlas-Based Autosegmentation, Computerized Medical Systems, Inc. (2008) Summary page 1.
- K083591: Ikoengelo, Version 2, Ikoetech, LLC (2008) Summary page 1.
- K071310: Syngo CT Oncology Software Package, Siemens AG (2007) 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
Segasist P-AC contouring software is a standalone software application for Windows platforms that assists clinicians in generating estimates of the anatomy boundary contours of the prostate gland in Computed Tomography (CT) scans, Magnetic Resonance (MR) images and ultrasound (sonography) scans to aid in patient diagnosis, treatment planning and post-treatment monitoring. The software is intended to be used to provide clinicians with tools to efficiently contour/delineate the prostate gland in volume data and save the results in DICOM and BMP format. The clinician has the ability to use the saved contours directly or import them in other software tools to perform the task at hand. The clinician retains the ultimate responsibility for making the pertinent diagnosis and patient management decisions based on their standard practices and visual comparison of the individual images. The Segasist P-AC software tool is a compliment to manual contouring techniques.

Source page: https://510kreport.com/device/K111311
Methodology: https://510kreport.com/methodology