# K994283: Mri- Magnetic Resonance Analytical Software System

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Aug 30, 2000 after 254 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940172 (1994). 2 ancestors in all.
68 later devices descend from it; 8 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993765: Quantitative Analysis of Left Ventricular Angiograms (QLV), Medis Medical Imaging Systems BV (1999) Summary page 1.

## Most influential descendants
- K073194: Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools (2008), 28 descendants of its own
- K031927: GE Delta Software Option for Mri (2003), 22 descendants of its own
- K121762: Cardiac VX (2013), 21 descendants of its own
- K140587: MR-CT Vva (2015), 19 descendants of its own
- K090833: Segment (2009), 13 descendants of its own

## Indications for use
MASS, including its option, has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function from cardiac MR data sets. The MASS software package can be used to semi-automatically calculate and display various parameters such as: EDV, ESV, stroke volume, ejection fraction; peak ejection and filling rates; myocardial mass; regional wall thickness, as well as wall thickening/thinning, and regional wall motion. When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.

Source page: https://510kreport.com/device/K994283
Methodology: https://510kreport.com/methodology