27 results
·
148ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMPAX Clinical Applications
FDA UDI
Agfa HealthCare NV·05400874001205·IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
Enterprise Imaging XERO Viewer
FDA UDI
Agfa HealthCare NV·05414904242919·
Enterprise Imaging Desktops
FDA UDI
Agfa HealthCare NV·05414904218525·ENT IMG SW 8.
Enterprise Imaging XERO Viewer
FDA UDI
Agfa HealthCare NV·05400874000710·Enterprise Imaging XERO Viewer 8.x
Enterprise Imaging Desktops
FDA UDI
Agfa HealthCare NV·05414904252437·
Enterprise Imaging XERO Viewer
FDA UDI
Agfa HealthCare NV·05414904252444·
Enterprise Imaging Xero Viewer
FDA UDI
Agfa HealthCare NV·05414904218532·ENT IMG SW XERO VIEWER 8.1
IMPAX
FDA UDI
Agfa HealthCare NV·05400874000727·IMPAX Software 6.X
Enterprise Imaging Desktops
FDA UDI
Agfa HealthCare NV·05414904242902·
Enterprise Imaging Desktops
FDA UDI
Agfa HealthCare NV·05400874000703·Enterprise Imaging Desktops 8.x
IMPAX
FDA UDI
Agfa HealthCare NV·05414904216552·IMPAX SW CLIENT V6.7
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
FDA Adverse Event
Malfunction
·AGFA N.V.·Product code IZL·January 9, 2019
DX-D600 - DXD IMAGING PACKAGE
FDA Adverse Event
Malfunction
·AGFA N.V.·Product code KPR·January 14, 2019
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
FDA Adverse Event
Malfunction
·AGFA N.V.·Product code IZL·January 9, 2019
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
FDA Adverse Event
Malfunction
·AGFA N.V.·Product code IZL·January 9, 2019
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
FDA Adverse Event
Malfunction
·AGFA N.V.·Product code IZL·November 13, 2018
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
FDA Adverse Event
Malfunction
·AGFA N.V.·Product code IZL·January 25, 2019
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)
FDA Enforcement
Class II
·Ongoing·Agfa Healthcare NV·October 16, 2024
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
FDA Enforcement
Class II
·Terminated·Agfa Healthcare NV·October 17, 2018
Agfa HealthCare Enterprise Imaging XERO Viewer
FDA Enforcement
Class II
·Ongoing·Agfa Healthcare NV·February 1, 2023