7 results
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30ms
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Sources: EU EUDAMED, US FDA
ISPG, INC.
FDA registration
ISPG, INC.·4 products·🇺🇸 United States
VITROS IMMUNODIAGNOSTIC PRODUCTS IPTH REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·May 13, 2011
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·December 12, 2019
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 12, 2013
THE VIEWING WAND
FDA Adverse Event
Malfunction
·ISG TECHNOLOGIES, INC.·Product code LLZ·July 17, 1996
RADSURE
FDA Adverse Event
Malfunction
·ISP TECHNOLOGIES, INC.·Product code MOT·March 27, 1998