BEUDAMED
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    AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.

    FDA Enforcement
    Class II ·Terminated·Agfa N.V.·August 7, 2019

    AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications

    FDA Enforcement
    Class II ·Terminated·Agfa N.V.·June 10, 2020

    AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·August 29, 2012

    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.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·June 12, 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. Agfa's DX-D 100 is not indicated for use in mammography.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·July 30, 2014

    Agfa HealthCare Enterprise Imaging XERO Viewer

    FDA Enforcement
    Class II ·Ongoing·Agfa Healthcare NV·February 1, 2023

    Agfa Healthcare NX 3.0.8950 Imaging Processing Software

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·July 26, 2017

    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

    FDA Enforcement
    Class II ·Terminated·Agfa N.V.·March 25, 2020

    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

    FDA Enforcement
    Class II ·Ongoing·AGFA Healthcare Corp.·December 31, 2025

    AGFA DX-D 100 is a mobile digital radiography x-ray system

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·June 17, 2015

    MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·October 12, 2016

    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.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·March 27, 2013

    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

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·April 5, 2017

    DX-D 600 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.

    FDA Enforcement
    Class II ·Terminated·Agfa N.V.·October 3, 2018

    DR 800. Digital Radiography X-ray System.

    FDA Enforcement
    Class II ·Ongoing·Agfa N.V.·September 4, 2024

    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.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·April 17, 2013

    IMPAX RIS QDOC 5.8

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·February 12, 2014

    IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·April 17, 2013

    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.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·August 1, 2012

    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·August 22, 2012