AccessGUDID - DEVICE: MIStar (B409MISTAR320)

GUDID

Device Identifier (DI) Information

Brand Name: MIStar
Version or Model: 3.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MISTAR32
Company Name: APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.

Primary DI Number: B409MISTAR320
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 742134034 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043350	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f73d9483-f981-4ea2-8e2e-4a6d95a80d50
Public Version Date: October 18, 2023
Public Version Number: 6
DI Record Publish Date: February 13, 2017