# K090833: Segment

- Pathway: 510(k) (Traditional)
- Applicant: Medviso
- Decided: May 12, 2009 after 47 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940172 (1994). 5 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994283: Mri- Magnetic Resonance Analytical Software System, Medis Medical Imaging Systems BV (2000) Summary page 4.
- K994282: Mri- Flow Analytical Software Package, Medis Medical Imaging Systems BV (2000) Summary page 4.

## Most influential descendants
- K111311: Segmentation Assistant for Prostate-Auto Contouring (2011), 9 descendants of its own
- 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

## Indications for use
Segment is a software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Segment specifically analyzes the function of the heart and its major vessels using multi-slice, multi-frame and velocity encoded MR images. It provides clinically relevant and reproducible data for supporting the evaluation of the function of the chambers of the heart such as left and right ventricular volumes, ejection fractions, stroke volumes, peak ejection and filling rates, myocardial mass, regional wall thickness, fractional thickening and wall motion. It also provides quantitative data on blood flow and velocity in the arterial vessels and at the heart valves. Segment is tested on MR images acquired from both 1.5 T and 3 T MR scanners. The data produced by Segment is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Source page: https://510kreport.com/device/K090833
Methodology: https://510kreport.com/methodology