AGFA Corp.

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2081-2014Class IIAGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing June 6, 2014
Z-1662-2014Class IIIMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character RecognitioApril 30, 2014
Z-0919-2014Class IIIMPAX RIS QDOC 5.8January 8, 2014
Z-0035-2014Class IIIMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and CommunicationSeptember 19, 2013
Z-1487-2013Class IIAGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing May 15, 2013
Z-1069-2013Class IIIMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effectivMarch 15, 2013
Z-1070-2013Class IIIMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates diMarch 15, 2013
Z-0970-2013Class IICR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, cFebruary 7, 2013
Z-2252-2012Class IIAGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with CardiovascularAugust 9, 2012
Z-2184-2012Class IIIMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured rJuly 27, 2012
Z-2069-2012Class IIIMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quickJuly 10, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K063421DX-SINovember 22, 2006
K053458WEB1000December 22, 2005
K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.XApril 21, 2005
K050810AGFA CR50.0April 21, 2005
K042779RADIOTHERAPY SOLUTION BASED ON CROctober 21, 2004
K041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEMJuly 22, 2004
K040555IMPAX CLIENT EMBRACEMay 26, 2004
K040344IMPAX OT3000 ORTHOPEDIC WORKSTATIONMay 12, 2004
K032635DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300September 24, 2003
K023287DRYSTAR 5500October 22, 2002
K023020AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSSeptember 26, 2002
K022292IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW September 12, 2002
K022658LR DICOM CONTROLLERSeptember 6, 2002
K021542ADC DENTALAugust 6, 2002
K012941DRYSTAR, MODEL 4500MNovember 29, 2001
K012750ADC PEDIATRICNovember 14, 2001
K012010MODIFICATION TO LR 5200 FILM RECORDERSeptember 20, 2001
K010571ADC QS/IPD WORKSTATIONMarch 28, 2001
K000159AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLOFebruary 16, 2000