9 results
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11ms
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Sources: EU EUDAMED, US FDA
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-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 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