Visage Breast Density

GUDID 04251332930008

Visage Imaging GmbH

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software
Primary Device ID04251332930008
NIH Device Record Key5c335224-0a3e-4bef-b07e-d912fc0215b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisage Breast Density
Version Model Number1.0
Company DUNS340229090
Company NameVisage Imaging GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS104251332930008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-10
Device Publish Date2021-04-30

Devices Manufactured by Visage Imaging GmbH

04251332920047 - Visage Ease Pro2024-03-08
04251332910055 - Visage 72023-10-18
04251332910086 - Visage 72023-06-23
04251332920030 - Visage Ease Pro2023-06-23
04251332910079 - Visage 72022-02-24
04251332930008 - Visage Breast Density2021-05-10
04251332930008 - Visage Breast Density2021-05-10
04251332910062 - Visage 72021-05-07
04251332920023 - Visage Ease Pro2020-03-17

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