Vitrea View

GUDID 00853866003650

Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and Multi-Media medical images. The Vitrea View software enables clinicians and other medical professionals to access patients’ medical images from 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. The Vitrea View software is a tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care. Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data with access to clinical reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians, clinicians and other medical professionals. The Vitrea View software is scalable due to the web-based zero-footprint architecture which allows sites to quickly and easily add new users as demand grows. The software may also be deployed in a virtualized environment.

VITAL IMAGES, INC.

Radiology PACS software

• Primary Device ID: 00853866003650
• NIH Device Record Key: 477a3e5f-ea9b-494e-989d-fc5571e63366
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrea View
• Version Model Number: 7.4
• 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	00853866003650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163232

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: 2019-03-11

On-Brand Devices [Vitrea View ]

• 00853866003698: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003674: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003650: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003407: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003377: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003353: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003346: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003315: 7.1.2
• 00853866003308: 7.1.1
• 00853866003292: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003285: Vitrea View is a medical image viewing and information distribution application that provides ac
• 00853866003261: VitreaView is a medical image viewing and information distribution application that provides acc
• 00853866003735: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003711: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003810: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003834: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003780: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003728: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003704: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003919: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00853866003964: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00850025268028: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00850025268059: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00850025268073: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu
• 00850025268103: Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solu