FDA.reportPublic FDA data

Visage Breast Density

Primary DI
04251332930008
Brand
Visage Breast Density
Company
Visage Imaging GmbH
Model
1.0
Published
2021-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201411000Visage Breast DensityVisage Imaging GmbH2021-01-29QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251332930008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251332930008042513329300084251332930008

GMDN Terms#

Term, Definition table
TermDefinition
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
340229090
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251332910109Visage 77.1.202026-04-09
04251332910093Visage 77.1.192025-06-10
04251332920047Visage Ease Pro2.22024-02-29
04251332910055Visage 77.1.152020-06-11
04251332910086Visage 77.1.182023-06-15
04251332920030Visage Ease Pro2.02023-06-15
04251332910079Visage 77.1.172022-02-16
04251332910062Visage 77.1.162021-04-29
04251332920023Visage Ease Pro1.122020-03-09
04251332910048Visage 77.1.142019-06-14
04251332910000Visage 77.1.92016-09-24
04251332910017Visage 77.1.102017-01-17
04251332910024Visage 77.1.112018-01-15
04251332910031Visage 77.1.122019-02-19
04251332920009Visage Ease Pro1.8.22016-09-24
04251332920016Visage Ease Pro1.102018-01-22

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Primary DI, Brand, Company table
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08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
00198715128956AngiowaveAngioWave Imaging, LLCQIH2026-05-09
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
B720BX360ECTA1430e-CTABRAINOMIX LIMITEDQIH2026-05-06
00860010264638EZRA PLEXO SOFTWAREEzra Ai, Inc.QIH2026-05-05
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
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00860000171243SubtleHD(MR)Subtle Medical, Inc.QIH2026-04-09
08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30
B720BX360ECTA1210Brainomix 360 e-CTABRAINOMIX LIMITEDQIH2026-03-30
08800066200626MEDIHUB PROSTATEJLK, Inc.QIH2026-03-25
00884838122154EchoNavigatorPhilips Medical Systems Nederland B.V.QIH2026-03-25
10603295562108VELYS Hip NavigationDEPUY ORTHOPAEDICS, INC.QIH2026-03-24
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.QIH2026-02-24
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTDQIH2026-02-18
B720BX360ECTA1420e-CTABRAINOMIX LIMITEDQIH2026-02-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
00195278932358Spectral Bone MarrowGE Medical Systems, L.L.C.QIH2026-01-26
00198953113554LOGIQGE Ultrasound Korea Ltd.QIH2026-01-26
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21