FDA.reportPublic FDA data

Visia LungCAD

Primary DI
04260483290084
Brand
Visia LungCAD
Company
MeVis Medical Solutions AG
Model
5.8
Device description
5.8.0.224889, Release date: 2017-12-135.8.1.246755, Release date: 2020-12-01
Published
2017-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OEBLung Computed Tomography System, Computer-Aided Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEBLung Computed Tomography System, Computer-Aided DetectionRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043617000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043617000IMAGECHECKER CT CAD SOFTWARE SYSTEMHologic, Inc.2007-12-21OEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260483290084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260483290084042604832900844260483290084

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315042296
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
04260483290312MammoScape1.1.42026-02-16
04260483290282MeVis Liver Suite1.3.2-IT2025-04-25
04260483290091Veolity1.42017-12-21
04260483290107Veolity LungCAD1.42017-12-21
04260483290244Veolity2.22025-01-09
04260483290053DynaCAD Lung2.22016-12-21
04260483290060DynaCAD Lung Server2.22016-12-21
04260483290169DynaSuite Neuro3.22020-01-08
04260483290077DynaSuite Neuro3.12016-12-12
04260483290268MeVis Liver Suite1.32024-01-15
04260483290176Veolity1.72021-03-18
04260483290183DynaCAD Lung2.42021-03-18
04260483290015Visia LungCAD5.72016-12-21
04260483290039Veolity1.32016-12-21
04260483290046Veolity LungCAD1.32016-12-21
04260483290114DynaCAD Lung2.32017-12-21
04260483290121DynaCAD Lung Server2.32017-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.OEB2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.OEB2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.OEB2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.OEB2026-04-20
M722CP25215V252150ClearRead CT Platform DockerRiverain Technologies, Inc.OEB2025-08-26
M722C25211V252110ClearRead CT ServerRiverain Technologies, Inc.OEB2025-08-26
M722CC25211V252110ClearRead CT ConsoleRiverain Technologies, Inc.OEB2025-08-26
M722CD25211V252110ClearRead CT DockerRiverain Technologies, Inc.OEB2025-08-26
M722C25119V251130ClearRead CT ServerRiverain Technologies, Inc.OEB2025-06-17
M722CC25113V251130ClearRead CT ConsoleRiverain Technologies, Inc.OEB2025-06-17
M722CD25113V251130ClearRead CT DockerRiverain Technologies, Inc.OEB2025-06-17
M722CP25113V251130ClearRead CT Platform DockerRiverain Technologies, Inc.OEB2025-06-17
00850003095042InferRead Lung CT.AIInfervision Medical Technology Co., LtdOEB2025-05-23
04260483290244VeolityMeVis Medical Solutions AGOEB2025-01-09
M722CP24281V242810ClearRead CT Platform DockerRiverain Technologies, Inc.OEB2024-10-16
M722C24281V242810ClearRead CT ServerRiverain Technologies, Inc.OEB2024-10-16
M722CC24281V242810ClearRead CT ConsoleRiverain Technologies, Inc.OEB2024-10-16
M722CD24281V242810ClearRead CT DockerRiverain Technologies, Inc.OEB2024-10-16
M722C24239V242390ClearRead CT ServerRiverain Technologies, Inc.OEB2024-09-18
M722CC24239V242390ClearRead CT ConsoleRiverain Technologies, Inc.OEB2024-09-18
M722CD24239V242390ClearRead CT DockerRiverain Technologies, Inc.OEB2024-09-18
M722CP24255V242550ClearRead CT Platform DockerRiverain Technologies, Inc.OEB2024-09-18
M722C24052V240250ClearRead CT ServerRiverain Technologies, Inc.OEB2024-03-11
M722CC24052V240250ClearRead CT ConsoleRiverain Technologies, Inc.OEB2024-03-11
M722CD24052V240450ClearRead CT DockerRiverain Technologies, Inc.OEB2024-03-11
M722CP24052V240520ClearRead CT Platform DockerRiverain Technologies, Inc.OEB2024-03-11
M722C24025V240250ClearRead CT ServerRiverain Technologies, Inc.OEB2024-02-08
M722CC24025V240250ClearRead CT ConsoleRiverain Technologies, Inc.OEB2024-02-08
M722CD24025V240250ClearRead CT DockerRiverain Technologies, Inc.OEB2024-02-08