# K133603: Philips CT Dynamic Myocardial Perfusion (DMP) Application

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Sep 25, 2014 after 304 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: 6 generations back to K930090 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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 5.
- K070226: Cardioct, Shina Systems, Ltd. (2007) Summary page 5.
- K060937: Brilliance Volume, Philips Medical Systems (Cleveland), Inc. (2006) Summary page 5.

## Indications for use
The CT Dynamic Myocardial Perfusion (CT DMP) application is intended to assist clinicians in the visualization and diagnostic assessment of cardiac images focusing on the left ventricular myocardium: specifically providing qualitative myocardial blood flow measurements for CT images. The application supports axial, ECG gated CT images, consisting of multiple time shots within the same study of the same myocardial region overtime (i.e., dynamic CT scans), after the injection of intravenous contrast. The application displays the results as a composite (single image that is calculated from a set of time course images at a single location) image.

Source page: https://510kreport.com/device/K133603
Methodology: https://510kreport.com/methodology