# K033677: Brain Perfusion Option

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 20, 2004 after 88 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: 4 generations back to K930090 (1993). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961464: Select/SP, Elscint, Inc. (1996) Summary page 2.
- K012009: MX8000 Idt CT System, Marconi Medical Systems, Inc. (2001) Summary page 2.
- (no number) Mx8000IDT: named in the summary without a submission number

## Most influential descendants
- K182716: Brain Perfusion (BP) application (2019), 1 descendant of its own
- K201573: Brain Perfusion (BP) application (2021), 0 descendants of its own
- K133603: Philips CT Dynamic Myocardial Perfusion (DMP) Application (2014), 0 descendants of its own

## Indications for use
The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected 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, 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. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System. The Brain Perfusion Option is used in a Philips Medical Systems Brilliance TM Workspace of a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Source page: https://510kreport.com/device/K033677
Methodology: https://510kreport.com/methodology