Agfa Corp.
Greenville, SC, US
Agfa Corp. appears in FDA device records in Greenville, SC. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 11 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Agfa Corp. between 2000 and 2006. The busiest year on record is 2002, with 4. The most recent is 2006, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2002 | 4 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K063421 | DX-SI | MQB | Substantially Equivalent | |
| K062742 | CR 85-X | MQB | Substantially Equivalent | |
| K062223 | AGFA MODEL CR30-X | MQB | Substantially Equivalent | |
| K053634 | COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION | MQB | Substantially Equivalent | |
| K052251 | DRYSTAR MODEL 5500 | LMC | Substantially Equivalent | |
| K050810 | AGFA CR50.0 | MQB | Substantially Equivalent | |
| K050751 | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X | LLZ | Substantially Equivalent | |
| K042779 | RADIOTHERAPY SOLUTION BASED ON CR | IXK | Substantially Equivalent | |
| K041701 | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM | MQB | Substantially Equivalent | |
| K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 | LMC | Substantially Equivalent | |
| K023287 | DRYSTAR 5500 | LMC | Substantially Equivalent | |
| K023020 | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE | IXA | Substantially Equivalent | |
| K022658 | LR DICOM CONTROLLER | LMC | Substantially Equivalent | |
| K021542 | ADC DENTAL | MUH | Substantially Equivalent | |
| K000159 | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO | IXK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
These records are listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings. | Class II | Terminated | |
| 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. | Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service. | Class II | Terminated | |
| Z-0919-2014 | IMPAX RIS QDOC 5.8 | Patient name displayed (printed) on the Patient Report was the wrong patient name. | Class II | Terminated | |
| Z-0035-2014 | IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). | System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. | Class II | Terminated | |
| 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. | Customers could potentially experience intermittent, unintended and illogical movement when using the product. | Class II | Terminated | |
| Z-1070-2013 | IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. | Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system. | Class II | Terminated | |
| 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. | Software design error in IMPAX CV 7.8 SU3 | Class II | Terminated | |
| 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. | The cassettes were shipped with the wrong IP (image plate) size bar code. | Class II | Terminated | |
| 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 | Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS). | Class II | Terminated | |
| Z-2184-2012 | IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) | Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report. | Class II | Terminated | |
| Z-2069-2012 | IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports. | When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain