Vitrea View

GUDID 00853866003285

Vitrea View is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. 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: 00853866003285
• NIH Device Record Key: 06d498cd-7e4e-4464-9d78-dc41da8d9ec9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrea View
• Version Model Number: 7.1
• 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	00853866003285 [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: 2017-06-26

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