60 results
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72ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IntelliSpace Clinical Applications
FDA UDI
Philips Healthcare Informatics, Inc.·00884838091849·Philips IntelliSpace Clinical Applications is a...
IntelliSpace PACS
FDA UDI
Philips Healthcare Informatics, Inc.·00884838074781·IntelliSpace PACS is an image management system...
IntelliSpace Radiology
FDA UDI
Philips Healthcare Informatics, Inc.·00884838091740·IntelliSpace Radiology Software (client) is a s...
iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
FDA Recall
Terminated
·Philips Healthcare Informatics, Inc.·Product code LLZ·August 29, 2008
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·February 13, 2009
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·February 1, 2010
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·March 11, 2010
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·May 17, 2010
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·April 26, 2010
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·April 26, 2010
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·December 2, 2009
ISITE PACS
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·August 3, 2011
ISITE PACS
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·November 18, 2008
ISITE PACS
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE INFORMATICS, INC·Product code LLZ·September 8, 2011
ISITE PACS
FDA Adverse Event
Injury
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·July 6, 2011
ISITE PACS
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·May 27, 2009
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·May 26, 2009
ISITE PACS
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE INFORMATICS INC·Product code LLZ·May 15, 2009
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·May 26, 2009
ISITE PACS
FDA Adverse Event
Other
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·June 4, 2009