MIStar MISTAR32

GUDID B409MISTAR320

MIStar is a software package, which runs on a Windows-based PC platform. It allows manipulation, visualization and processing of medical images acquir

APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.

Radiology picture archiving and communication system application software

• Primary Device ID: B409MISTAR320
• NIH Device Record Key: f73d9483-f981-4ea2-8e2e-4a6d95a80d50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIStar
• Version Model Number: 3.2
• Catalog Number: MISTAR32
• Company DUNS: 742134034
• Company Name: APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B409MISTAR320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043350

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2017-02-13