10,000 results
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60ms
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Sources: EU EUDAMED, US FDA
IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.
FDA Recall
Terminated
·AGFA Corp.·Product code LMD·December 11, 2007
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
IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to.
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·April 5, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·December 22, 2016
IMPAX CV12
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·September 1, 2015
IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON
FDA Adverse Event
Other
·AGFA HEALTHCARE CORP.·Product code LMB·March 13, 2012
IMPAX CV CARDIOVASCULAR REVIEW STATION
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·January 7, 2012
IMPAX CV REPORTING
FDA Adverse Event
Other
·AGFA HEALTHCARE CORP.·Product code LLZ·March 20, 2012
AGFA IMPAX VERSION 5.2
FDA Adverse Event
Injury
·AGFA HEALTHCARE CORP.·Product code LLZ·March 13, 2009
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·April 30, 2014
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 17, 2014
IMPAX CV OUTBOUND(RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 17, 2014
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE, CORP.·Product code LLZ·June 25, 2014
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 6, 2014
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 17, 2014
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 17, 2014
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·June 17, 2014
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 17, 2014
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·May 14, 2014
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 6, 2014