Vitrea Read

GUDID 00628105001045

Vitrea Read 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. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

Radiology PACS software
Primary Device ID00628105001045
NIH Device Record Key0033c125-4a50-490f-8735-b3e0efb5d94a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitrea Read
Version Model Number8.5.0
Company DUNS307092283
Company NameCanon Medical Informatics 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
GS100628105001045 [Primary]

FDA Product Code

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 Date2023-09-26
Device Publish Date2023-09-18

On-Brand Devices [Vitrea Read]

00628105001007Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001038Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001052Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001076Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001045Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001090Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001113Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001137Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001120Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001106Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001144Vitrea Read is a software only medical device providing tools and features that may be used for
00628105001151Vitrea Read is a software only medical device providing tools and features that may be used for

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