# K043350: Mistar, Model V3.2

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Medical Imaging Technology Pty., Ltd.
- Decided: Dec 15, 2004 after 9 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: 5 generations back to K896095 (1990). 10 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 1.
- K010042: CT Perfusion 2, General Electric Co. (2001) Summary page 1.
- K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 1.

## Most influential descendants
- K052963: Mediq Version 1.0 (2005), 11 descendants of its own
- K080196: Z3D Contrast Acuity (2008), 10 descendants of its own
- K081556: Cadstream, Version 5.0 (2009), 9 descendants of its own
- K092954: Cadstream Version 5 (2009), 8 descendants of its own
- K170195: QuantX (2017), 4 descendants of its own

## Indications for use
MIStar is a software package that provides manipulation, visualization and processing of medical images in a diagnostic imaging setting. It allows transfer of DICOM 3.0 images over a medical imaging network, and can receive digital images and data from various sources (including but not limited to CT, MR, NM, and PT). MIStar supports the analysis of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media. It allows visual inspection of time intensity curves and calculation of parametric parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also calculates various blood perfusion related parameters such as blood flow (BF), blood volume (BV), mean transit time (MTT) and capillary permeability from dynamic CT images. This software provides supplemental information to those images extracted from CT and MR temporal datasets and will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes related but not limited to stroke or tumor angiogenesis and be helpful in therapy monitoring. MIStar is intended to be used by trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.

Source page: https://510kreport.com/device/K043350
Methodology: https://510kreport.com/methodology