# K083084: CT Brain Perfusion for Ziostation

- Pathway: 510(k) (Traditional)
- Applicant: Ziosoft, Inc.
- Decided: Dec 19, 2008 after 64 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 K913770 (1991). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072821: Vitrea 4DCT, Vital Images, Inc. (2008) Summary page 1.

## Indications for use
Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication: The CT Brain Perfusion for Ziostation option is an image analysis software package providing additional image processing capabilities to the basic Ziostation device. The CT Brain Perfusion for Ziostation option is intended for post-processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

Source page: https://510kreport.com/device/K083084
Methodology: https://510kreport.com/methodology