MIStar

Primary DI
B409MISTAR320
Brand
MIStar
Company
APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.
Model
3.2
Catalog number
MISTAR32
Device 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.
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043350000MISTAR, MODEL V3.2Apollo Medical Imaging Technology Pty. , Ltd.2004-12-15LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B409MISTAR320PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
742134034
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
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00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
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00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
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