Vitrea Enterprise Viewer

GUDID 00853866003223

VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning. VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero footprint/zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

VITAL IMAGES, INC.

Radiology PACS software

• Primary Device ID: 00853866003223
• NIH Device Record Key: b5ac5217-5a82-44bd-9be6-9b746812de4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrea Enterprise Viewer
• Version Model Number: 7.0
• Company DUNS: 160061651
• Company Name: VITAL IMAGES, 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: true
• 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	00853866003223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150738

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: 2019-05-23
• Device Publish Date: 2017-03-15

Devices Manufactured by VITAL IMAGES, INC.

• 00850025268103 - Vitrea View: 2022-04-12 Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both
• 00850025268066 - Vitrea Advanced Visualization: 2022-04-07 The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communic
• 00850025268097 - Vitrea Advanced Visualization: 2022-03-14 The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communic
• 00850025268073 - Vitrea View: 2022-03-10 Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both
• 00850025268035 - Vitrea Advanced Visualization: 2022-01-17 The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communic
• 00850025268059 - Vitrea View: 2021-12-27 Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both
• 00850025268042 - Vitrea Advanced Visualization: 2021-11-19 The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communic
• 00850025268011 - Vitrea Advanced Visualization: 2021-10-06 The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communic