Agfa Healthcare NV

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
3
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0923-2026Class IIBrand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800November 18, 2025
Z-0055-2025Class IIEnterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of muSeptember 6, 2024
Z-1004-2023Class IIAgfa HealthCare Enterprise Imaging XERO ViewerDecember 5, 2022
Z-0101-2019Class IIEnterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when dAugust 3, 2018
Z-2652-2017Class IIIMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interfDecember 22, 2016
Z-2735-2017Class IIAgfa Healthcare NX 3.0.8950 Imaging Processing SoftwareDecember 21, 2016
Z-1738-2017Class IIDX-D600 - DXD Imaging PackageMay 2, 2016
Z-1698-2017Class IIAGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic January 20, 2016
Z-0283-2016Class IIIMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. CorrectsSeptember 1, 2015
Z-2061-2015Class IIIMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communicationsJune 26, 2015
Z-1745-2015Class IIAGFA DX-D 100 is a mobile digital radiography x-ray systemMay 29, 2015
Z-0804-2015Class IIIRadiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4COctober 24, 2014
Z-2178-2014Class IIIRadiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 1July 16, 2014
Z-2175-2014Class IIDX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic qualityJuly 2, 2014
Z-2176-2014Class IIIAgfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing May 13, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K071972ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONSJuly 30, 2007
K071297IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)June 22, 2007
K071162AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONSMay 8, 2007