AGFA Healthcare Corp.
Goose Creek, SC, US
AGFA HEALTHCARE CORP. appears in FDA device records in Goose Creek, SC. FDA records list 39 510(k) clearances between and , no PMA records and 8 registered establishments. As of , FDA records show 73 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to AGFA Healthcare Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Agfa Gevaert N.V.registration, 510(k), enforcement report, recall
- Agfa US Corporationregistration
510(k) clearance history
FDA records hold 39 510(k) clearances for AGFA Healthcare Corp. between 1979 and 2025. The busiest year on record is 2007, with 5. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1983 | 1 |
| 1988 | 1 |
| 2001 | 1 |
| 2007 | 5 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 5 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 5 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252199 | AGFA HealthCare Enterprise Imaging | LLZ | Substantially Equivalent | |
| K180589 | DR 800 with MUSICA Dynamic | JAA | Substantially Equivalent | |
| K172784 | DX-D Imaging Package | MQB | Substantially Equivalent | |
| K170434 | Enterprise Imaging XERO Viewer 8.1 | LLZ | Substantially Equivalent | |
| K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) | MQB | Substantially Equivalent | |
| K161061 | IMPAX Volume Viewing 4.0 | LLZ | Substantially Equivalent | |
| K152639 | DR 600 | MQB | Substantially Equivalent | |
| K143397 | ICIS View | LLZ | Substantially Equivalent | |
| K142316 | IMPAX Agility | LLZ | Substantially Equivalent | |
| K142184 | DX-D IMAGING PACKAGE | MQB | Substantially Equivalent | |
| K141602 | DX-D IMAGING PACKAGE | MQB | Substantially Equivalent | |
| K141192 | DR 400 | MQB | Substantially Equivalent | |
| K133135 | IMPAX VOLUME VIEWING 3.0 | LLZ | Substantially Equivalent | |
| K132800 | SKINTELL | NQQ | Substantially Equivalent | |
| K131408 | CR 12-X DIGITIZER | MQB | Substantially Equivalent | |
| K122736 | DX-D IMAGING PACKAGE | MQB | Substantially Equivalent | |
| K121095 | DX-D IMAGING PACKAGE | MQB | Substantially Equivalent | |
| K121948 | CR 10-X DIGITIZER | MQB | Substantially Equivalent | |
| K111324 | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER | MUE | Substantially Equivalent | |
| K112670 | DX-D 600 | KPR | Substantially Equivalent | |
| K111945 | IMPAX NEXT GENERATION | LLZ | Substantially Equivalent | |
| K111638 | IMPAX VOLUME VIEWING | LLZ | Substantially Equivalent | |
| K103597 | DX-D 100 | IZL | Substantially Equivalent | |
| K103050 | DX-D 300 | KPR | Substantially Equivalent | |
| K092669 | DX-D IMAGING PACKAGE | MQB | Substantially Equivalent | |
| K092238 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS | MQB | Substantially Equivalent | |
| K090672 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS | MQB | Substantially Equivalent | |
| K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION | LLZ | Substantially Equivalent | |
| K081963 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS | MQB | Substantially Equivalent | |
| K080013 | REGISTRATION AND FUSION | LLZ | Substantially Equivalent | |
| K073271 | ORTHOGON | LLZ | Substantially Equivalent | |
| K072680 | DRYSTAR AXYS, MODEL EYZ4E | LMC | Substantially Equivalent | |
| K071972 | ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS | LLZ | Substantially Equivalent | |
| K071297 | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) | LLZ | Substantially Equivalent | |
| K071162 | AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS | MQB | Substantially Equivalent | |
| K013138 | ADC COMPACT PLUS | MQB | Substantially Equivalent | |
| K882096 | SCOPIX VIDEO IMAGER | LMC | Substantially Equivalent | |
| K832603 | CURIX CAPACITY FILM CENTER | IXW | Substantially Equivalent | |
| K790273 | MAMMOGRAPHY SYSTEM AND CASSETTE | IZH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2249582 | 1000322596 | AGFA HEALTHCARE CORP. | 580 GOTHAM PARKWAY, CARLSTADT, NJ 07072 US | 2026 | No device listings on this registration |
| 9680497 | 3008794078 | AGFA HEALTHCARE INC. | 375 Hagey Boulevard, WATERLOO Ontario N2L 6R5 CA | 2026 | |
| 9616389 | 3009471886 | AGFA HEALTHCARE N.V. | SEPTESTRAAT 27, MORTSEL Antwerpen B 2640 BE | 2026 | |
| 3002809633 | 3002809633 | Agfa Gevaert N.V. | 27 Septestraat, Mortsel Antwerpen B 2640 BE | 2026 | |
| 3009238175 | 3009238175 | Agfa HealthCare | Moutstraat 100, Gent West-Vlaanderen B-9000 BE | 2026 | |
| 3009238185 | 3009238185 | Agfa HealthCare GmbH | Diefenbachgasse 35, Vienna Wien 1150 AT | 2026 | |
| 1065979 | 3002645723 | Agfa US Corporation | 1658 Bushy Park Rd, GOOSE CREEK, SC 29445 US | 2026 | No device listings on this registration |
| 3014527924 | 1000322596 | Agfa US Corporation | 580 GOTHAM PARKWAY, Carlstadt, NJ 07072 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LMCCamera, Multi Format, Radiological
- IWZFilm, Radiographic
- MUEFull Field Digital, System, X-Ray, Mammographic
- IXWProcessor, Radiographic-Film, Automatic
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZHSystem, X-Ray, Mammographic
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- HWTTemplate
Recall records
Showing 25 of 73| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0923-2026 | Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800 | It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled. | Class II | Open, Classified | |
| Z-0055-2025 | Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s) | Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations. | Class II | Open, Classified | |
| Z-1004-2023 | Agfa HealthCare Enterprise Imaging XERO Viewer | There is a software defect that can cause issues with images. | Class II | Open, Classified | |
| Z-0692-2019 | DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. | After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead of stopping while the movement button is released, the Tube Head Crane moves to the intended position. | Class II | Terminated | |
| Z-0101-2019 | Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. | Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top. | Class II | Terminated | |
| Z-2652-2017 | IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats | A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm. | Class II | Terminated | |
| Z-2735-2017 | Agfa Healthcare NX 3.0.8950 Imaging Processing Software | A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS. | Class II | Terminated | |
| Z-1738-2017 | DX-D600 - DXD Imaging Package | One of the dent markers from the DX-D600 dropped down from the overhead rail. | Class II | Terminated | |
| Z-1698-2017 | AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis | The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored. | Class II | Terminated | |
| Z-0283-2016 | IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed. | Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct. | Class II | Terminated | |
| Z-2061-2015 | IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. | Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect. | Class II | Terminated | |
| Z-1745-2015 | AGFA DX-D 100 is a mobile digital radiography x-ray system | When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. | Class II | Terminated | |
| Z-0804-2015 | Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM | Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed. | Class III | Terminated | |
| Z-2178-2014 | Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures. | Some sheets of the medical screen film are fogged. | Class III | Terminated | |
| Z-2175-2014 | DX-D 600 - DXD Imaging Package Product Usage: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, check abdomen and other both parts. | Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement. | Class II | Terminated | |
| 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-2176-2014 | Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses. | Unit was mislabeled with a factory label showing 32 KW output power. | Class III | 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 |
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Data as of , FDA export datePage updated Source: openFDA, public domain