# K130278: MR Permeability

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: May 29, 2013 after 113 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: 8 generations back to K896095 (1990). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090546: Modification to Nordicice Software, Nordicimaginglab AS (2009) Summary page 2.

## Most influential descendants
- K143368: GenIQ (2015), 0 descendants of its own

## Indications for use
MR Permeability facilitates the radiologist in visualizing and post-processing dynamic contrast-enhanced datasets. It is an optional package within IntelliSpace Portal. MR Permeability can be used by the radiologist to assess the micro-vascular properties by computing vascular permeability (Ktrans), tracer efflux rate (Kep), extravascular volume fraction (ye), plasma fraction (Vp), and Area under the curve (AUC) from Ti images of brain and prostate. The applied pharmacokinetic modeling is based on the Tofts model: The results are presented back to the user in the form of a parametric map, a table of results and in a graph. MR Permeability facilitates the visualization of areas with increased permeability. MR Permeability facilitates the visualization of variations in permeability. MR Permeability is a software tool for visualizing and post processing dynamic contrast-enhanced 3D datasets, acquired to visualize areas with abnormal vascularity.

Source page: https://510kreport.com/device/K130278
Methodology: https://510kreport.com/methodology