# K192912: AutoMIStar

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Medical Imaging Technology Pty., Ltd.
- Decided: Dec 31, 2019 after 77 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)
- K121447: Ischema View Rapid, Ischemaview, Inc. (2013) Summary page 4.

## Indications for use
AutoMIStar is a medical image post-processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard “off-the-shelf” computer or a virtual platform with Windows operating system, and can be used to perform image viewing, processing and analysis of brain images acquired by DICOM compliant imaging devices. AutoMIStar provides general viewing of DICOM images, with analysis capabilities for functional imaging data including a CT Perfusion Module and a DWI (diffusion-weighted MRI) Module. The CT Perfusion Module is used for visualization and analysis of contrast enhanced CT Perfusion (CTP) dataset, showing properties of changes in contrast over time. This function includes calculation of various parameters related to tissue flow (perfusion) and tissue blood volume. The DWl Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.

Source page: https://510kreport.com/device/K192912
Methodology: https://510kreport.com/methodology