EasyViz

GUDID 00628105001755

EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians.

Karos Health A/S

Radiology PACS software

• Primary Device ID: 00628105001755
• NIH Device Record Key: e78bc39f-32ee-4942-b9e9-617c189dbf72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyViz
• Version Model Number: 7.5
• Company DUNS: 307092283
• Company Name: Karos Health A/S
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628105001755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051809

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: 3
• Public Version Date: 2019-05-23
• Device Publish Date: 2018-08-20

On-Brand Devices [EasyViz]

• 00628105001762: EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
• 00628105001755: EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
• 00628105001748: EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
• 00628105001731: EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
• 62810500000024: EsayVIz is a diagnostic software image display workstation that has the ability to work with EMR
• 00628105001779: EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
• 00628105001809: EasyViz is a software only medical device providing tools and features that may be used for gene
• 00628105001816: EasyViz is a software only medical device providing tools and features that may be used for gene
• 00628105001830: EasyViz is a software only medical device providing tools and features that may be used for gene