AGFA Corp.
FDA Regulatory Profile
AGFA Corp. appears in FDA public data with 11 recalls, 19 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2081-2014, Class II) was initiated on June 6, 2014. Its most recent 510(k) clearance was granted on November 22, 2006.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2081-2014 | Class II | AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing | June 6, 2014 |
| Z-1662-2014 | Class II | IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognitio | April 30, 2014 |
| Z-0919-2014 | Class II | IMPAX RIS QDOC 5.8 | January 8, 2014 |
| Z-0035-2014 | Class II | IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication | September 19, 2013 |
| Z-1487-2013 | Class II | AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing | May 15, 2013 |
| Z-1069-2013 | Class II | IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effectiv | March 15, 2013 |
| Z-1070-2013 | Class II | IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates di | March 15, 2013 |
| Z-0970-2013 | Class II | CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, c | February 7, 2013 |
| Z-2252-2012 | Class II | AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular | August 9, 2012 |
| Z-2184-2012 | Class II | IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured r | July 27, 2012 |
| Z-2069-2012 | Class II | IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick | July 10, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K063421 | DX-SI | November 22, 2006 |
| K053458 | WEB1000 | December 22, 2005 |
| K050810 | AGFA CR50.0 | April 21, 2005 |
| K050751 | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X | April 21, 2005 |
| K042779 | RADIOTHERAPY SOLUTION BASED ON CR | October 21, 2004 |
| K041701 | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM | July 22, 2004 |
| K040555 | IMPAX CLIENT EMBRACE | May 26, 2004 |
| K040344 | IMPAX OT3000 ORTHOPEDIC WORKSTATION | May 12, 2004 |
| K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 | September 24, 2003 |
| K023287 | DRYSTAR 5500 | October 22, 2002 |
| K023020 | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASS | September 26, 2002 |
| K022292 | IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW | September 12, 2002 |
| K022658 | LR DICOM CONTROLLER | September 6, 2002 |
| K021542 | ADC DENTAL | August 6, 2002 |
| K012941 | DRYSTAR, MODEL 4500M | November 29, 2001 |
| K012750 | ADC PEDIATRIC | November 14, 2001 |
| K012010 | MODIFICATION TO LR 5200 FILM RECORDER | September 20, 2001 |
| K010571 | ADC QS/IPD WORKSTATION | March 28, 2001 |
| K000159 | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO | February 16, 2000 |