Ziostation2

GUDID 04571320222008

Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound,Digital X-ray X-ray Angiography, PET, SPECT, NM, SC, Mammography, X-ray Radiofluoroscopic image, RTImage.

ZIOSOFT, INC.

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• Primary Device ID: 04571320222008
• NIH Device Record Key: eece1bf9-b107-4db4-93b6-979f668d2af4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ziostation2
• Version Model Number: Ziostation2
• Company DUNS: 693942471
• Company Name: ZIOSOFT, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04571320222008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151212

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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-06-30