4 results
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74ms
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Sources: EU EUDAMED, US FDA
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Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·August 27, 2014
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·May 28, 2014
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
FDA Enforcement
Class II
·Completed·Philips Healthcare Informatics, Inc.·June 17, 2020