# K161601: Dynamika

- Pathway: 510(k) (Traditional)
- Applicant: Image Analysis Limited
- Decided: May 17, 2017 after 342 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: 11 generations back to K896095 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132095: Olea Sphere, Olea Medical (2013) Summary page 5.

## Indications for use
Dynamika Version 5.0 is an image processing software package to be used by trained medical professionals with a level of medical expertise (including physicians, radiographers and radiology technicians). The software runs on a standard off-the-shelf workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Dynamika Version 5.0 provides both viewing and analysis capabilities of dynamic imaging datasets acquired with MRI. Dynamika Version 5.0 is used for the visualization, analysis and reporting of dynamic MRI data, showing the properties of changes in contrast over time. The package may be used to calculate permeability parameters related to the leakage of injected contrast material from intravascular to extracellular space. Parametric maps may be overlaid onto the original image for interpretation. Dynamika Version 5.0 is intended to be used within hospitals and medical clinics. It is licensed and not intended for general public use.

Source page: https://510kreport.com/device/K161601
Methodology: https://510kreport.com/methodology