Duns Number:160061651
Device Description: VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image view 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.
Catalog Number
-
Brand Name
Vitrea Enterprise Viewer
Version/Model Number
7.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150738
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
b5ac5217-5a82-44bd-9be6-9b746812de4b
Public Version Date
April 26, 2022
Public Version Number
6
DI Record Publish Date
March 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |