Agfa Corp.
Agfa Corp. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2006, with 11 FDA device recalls on record.
Top product codes for Agfa Corp.
FDA recalls by Agfa Corp.
10 most recent of 11- Z-2081-2014 — AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.
- Z-1662-2014 — IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
- Z-0919-2014 — IMPAX RIS QDOC 5.8
- Z-0035-2014 — IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
- Z-1487-2013 — AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
- Z-1069-2013 — IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
- Z-1070-2013 — IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
- Z-0970-2013 — CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.
- Z-2252-2012 — AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
- Z-2184-2012 — IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Agfa Corp.
- K063421 — DX-SI
- K053458 — WEB1000
- K050751 — IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
- K050810 — AGFA CR50.0
- K042779 — RADIOTHERAPY SOLUTION BASED ON CR
- K041701 — AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
- K040555 — IMPAX CLIENT EMBRACE
- K040344 — IMPAX OT3000 ORTHOPEDIC WORKSTATION
- K032635 — DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
- K023287 — DRYSTAR 5500
- K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
- K022292 — IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO
- K022658 — LR DICOM CONTROLLER
- K021542 — ADC DENTAL
- K012941 — DRYSTAR, MODEL 4500M
- K012750 — ADC PEDIATRIC
- K012010 — MODIFICATION TO LR 5200 FILM RECORDER
- K010571 — ADC QS/IPD WORKSTATION
- K000159 — AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
Data sourced from openFDA. This site is unofficial and independent of the FDA.