Ziostation ZIOE1001SYS

GUDID B131ZIOE1001SYS0P

A self-standing software program that adds specific image processing and/or analysis capabilities to radiological DICOM image data.

QI IMAGING LLC

Radiology DICOM image processing application software

• Primary Device ID: B131ZIOE1001SYS0P
• NIH Device Record Key: 1fbf2a72-ddcd-4226-b9f1-fe67068cdf9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ziostation
• Version Model Number: 2.4.3.1
• Catalog Number: ZIOE1001SYS
• Company DUNS: 606828924
• Company Name: QI IMAGING LLC
• 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: false
• 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	B131ZIOE1001SYS0P [Primary]

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: 2019-10-07
• Device Publish Date: 2017-02-12