3 results
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42ms
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Sources: EU EUDAMED, US FDA
Agfa Gevaert N.V.
FDA registration
Agfa Gevaert N.V.·1 product·🇧🇪 Belgium
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 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