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MIStar

FDA UDI

Class II (US FDA UDI)

by Apollo Medical Imaging Technology Pty. , Ltd.

Identity

Trade Name
MIStar FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
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. FDA UDI
Model / Reference
3.2 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
MISTAR32 FDA UDI
Primary DI / UDI-DI
B409MISTAR320 FDA UDI
510(k) Number
K043350 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiological PACS software

MIStar by Apollo Medical Imaging Technology Pty. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apollo Medical Imaging Technology Pty. , Ltd.

Sources (1)

  • FDA UDI f73d9483-f981-4ea2-8e2e-4a6d95a80d50 35 fields · synced Jun 8, 2026