EasyViz

GUDID 00628105001762

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 a 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: 00628105001762
• NIH Device Record Key: 91d56e1e-3e5a-4777-ba06-5b77fdbe4758
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyViz
• Version Model Number: 7.6
• 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	00628105001762 [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: 2
• Public Version Date: 2019-05-23
• Device Publish Date: 2018-12-17

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