# K163076: Segment CMR

- Pathway: 510(k) (Traditional)
- Applicant: Medviso AB
- Decided: Apr 5, 2017 after 153 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: 5 generations back to K900889 (1990). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 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 4.
- K073194: Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools, Cardiovascular Imaging Solutions, Ltd. (2008) Summary page 4.
- K111833: Virtue, Diagnosoft, Inc. (2011) Summary page 4.
- K100352: Diagnosoft Harp Model 2.06, Diagnosoft, Inc. (2010) Summary page 4.

## Most influential descendants
- K232007: CAAS MR Solutions (2024), 0 descendants of its own
- K211611: QIR Suite (2022), 0 descendants of its own

## Indications for use
Segment CMR is a software that display and analyzes medical images in DICOM-format using multi-slice, multi-frame and velocity encoded MR images. Segment CMR provides features for analysis of cardiac function, such as cardiac pumping and blood flow. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. Images and associated data analysis can be stored, communicated, rendered, and displayed within the system and across PACS system. The data produced by Segment CMR 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/K163076
Methodology: https://510kreport.com/methodology