FDA.reportPublic FDA data

Enterprise Imaging Xero Viewer

Primary DI
05414904218532
Brand
Enterprise Imaging Xero Viewer
Company
Agfa HealthCare NV
Model
Enterprise Imaging Xero Viewer 8.1
Catalog number
5873H
Device description
ENT IMG SW XERO VIEWER 8.1
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143397000ICIS ViewAgfa Healthcare N.V.2015-06-01LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414904218532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414904218532054149042185325414904218532

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

Contacts#

Phone, Email table
PhoneEmail
+1(877)777-2432salesinfo@agfa.com

Regulatory Flags#

DUNS number
282853795
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05400874000703Enterprise Imaging Desktops82019-07-22
05400874000710Enterprise Imaging XERO Viewer82019-07-22
05400874000727IMPAX62019-07-22
05400874001205IMPAX Clinical Applications42019-07-22
05414904216552IMPAXIMPAX 6.758B5Y2016-09-16
05414904218525Enterprise Imaging DesktopsEnterprise Imaging Desktops 8.15872F2016-09-16
05414904242902Enterprise Imaging Desktops8.1.1XDFNZ2018-03-14
05414904242919Enterprise Imaging XERO Viewer8.1.1XDFO22018-03-14
05414904252437Enterprise Imaging Desktops8.1.2XFNCQ2018-03-14
05414904252444Enterprise Imaging XERO Viewer8.1.2XFNK52018-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26