# K182716: Brain Perfusion (BP) application

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: May 29, 2019 after 244 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K971684 (1997). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033677: Brain Perfusion Option, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 6.
- K152602: Olea Sphere V3.0, Olea Medical (2016) Summary page 6.

## Most influential descendants
- K201573: Brain Perfusion (BP) application (2021), 0 descendants of its own

## Indications for use
The Philips Medical Systems' Brain Perfusion (BP) application is a post processing software application intended to assist with the evaluation of an area of interest, to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast agent, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images.

Source page: https://510kreport.com/device/K182716
Methodology: https://510kreport.com/methodology