EasyViz

GUDID 00628105001809

EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Karos Health A/S

Radiology PACS software Radiology PACS software Radiology PACS software
Primary Device ID00628105001809
NIH Device Record Key571c66be-b03d-4c23-9f2a-3998dad66bdf
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasyViz
Version Model Number8.0
Company DUNS307092283
Company NameKaros Health A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628105001809 [Primary]
GS100628105001809 [Primary]
GS100628105001809 [Primary]

FDA Product Code

LMDSystem, Digital Image Communications, Radiological
LMDSystem, Digital Image Communications, Radiological
LMDSystem, Digital Image Communications, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [EasyViz]

00628105001762EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
00628105001755EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
00628105001748EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
00628105001731EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
62810500000024EsayVIz is a diagnostic software image display workstation that has the ability to work with EMR
00628105001779EasyViz is a diagnostic software image display workstation that has the ability to work with EMR
00628105001809EasyViz is a software only medical device providing tools and features that may be used for gene

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.