MIStar - MIStar is a software package, which runs on a - APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.

Duns Number:742134034

Device Description: MIStar is a software package, which runs on a Windows-based PC platform. It allows manipul MIStar is a software package, which runs on a Windows-based PC platform. It allows manipulation, visualization and processing of medical images acquired with various clinical scanners and stored in DICOM and /or other proprietary formats. MIStar allows transfer of DICOM 3.0 images over a medical imaging network.MIStar also provides post-processing of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer. 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 allows calculation of various perfusion related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability) from dynamic CT data. The results are displayed in a user-friendly graphic format as parametric images that provide supplementary information for diagnosis purposes.

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More Product Details

Catalog Number

MISTAR32

Brand Name

MIStar

Version/Model Number

3.2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K043350

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

f73d9483-f981-4ea2-8e2e-4a6d95a80d50

Public Version Date

May 23, 2019

Public Version Number

5

DI Record Publish Date

February 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1