5 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Ingenuity TF PET/CT 882442
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018
Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated acquisitions. This system is intended for patients of all ages
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 21, 2018
Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018