# K994282: Mri- Flow Analytical Software Package

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Mar 2, 2000 after 73 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: 1 generation back to K924605 (1993). 1 ancestor in all.
73 later devices descend from it; 7 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924605: Magnetic Resonance Diagnostic Accessory, General Electric Co. (1993) Summary page 1.

## Most influential descendants
- K031927: GE Delta Software Option for Mri (2003), 22 descendants of its own
- K121762: Cardiac VX (2013), 21 descendants of its own
- K091262: MR Cardiac Function Analysis (2009), 21 descendants of its own
- K103465: Synapse 3D Cardiac Tools (2011), 20 descendants of its own
- K140587: MR-CT Vva (2015), 19 descendants of its own

## Indications for use
FLOW has been developed for the objective and reproducible analysis of velocity-encoded cine MR imaging studies of arterial vessels and heart valves. FLOW software package enables to semi-automatically calculate and display all parameters: mean velocity (also minimum, maximum and standard deviation) and volume flow through region of interest (ROI); velocity and volume flow as function of time; stroke volume and cardiac output. Although therefore a qualified physician these parameters may be useful in establishing the determination of a diagnosis.

Source page: https://510kreport.com/device/K994282
Methodology: https://510kreport.com/methodology