# K231570: StrokeViewer Perfusion

- Pathway: 510(k) (Traditional)
- Applicant: Nico-Lab B.V.
- Decided: Dec 14, 2023 after 197 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: 13 generations back to K896095 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182130: iSchemaView RAPID, Ischemaview, Inc. (2018) Summary page 6.

## Indications for use
StrokeViewer Perfusion is an image processing software package intended to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients. It is to be used by medical imaging professionals who analyze dynamic perfusion studies, including but not limited to physicians such as neurologists, and radiologists. The software is packed as a Docker container allowing installation on a standard “off-the-shelf” computer or a virtual platform. The software can be used to perform image viewing, processing, and analysis of brain CT perfusion (CTP) images. Data and images are acquired through DICOM compliant imaging devices. StrokeViewer Perfusion is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time, which are visualized as colored perfusion maps including flow-related parameters and tissue blood volume quantification. Contraindications: - Bolus Quality: absent or inadequate bolus. - Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate - Presence of hemorrhage

Source page: https://510kreport.com/device/K231570
Methodology: https://510kreport.com/methodology