BEUDAMED
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    Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·January 16, 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. Agfa's DX-D 100 is not indicated for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code IZL·June 6, 2014

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

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IZL·May 29, 2015

    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 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

    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.

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    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.

    FDA Enforcement
    Class II ·Terminated·Agfa-Gevaert, N.V.·January 16, 2019

    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 Recall
    Terminated ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code KPR·August 15, 2018

    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 Recall
    Terminated ·AGFA Corp.·Product code IZL·May 15, 2013

    DX-D600 - DXD Imaging Package

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code KPR·May 2, 2016

    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.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code KPR·July 2, 2014

    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.

    FDA Recall
    Terminated ·Agfa-Gevaert, N.V. Prins Boudewijnlaan Kontich Belgium·Product code KPR·December 4, 2018

    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JWH·July 1, 2021

    DX-D600 - DXD Imaging Package

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·April 12, 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

    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.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IZL·May 13, 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.

    FDA Enforcement
    Class III ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 25, 2021

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

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

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

    FDA Recall
    Terminated ·Product code LPS·March 20, 2015