FDA-Device2019-02-20Class II
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 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 imagin
Philips Medical Systems (Cleveland) Inc
Hazard
A software update is being issued to correct multiple issues identified in the previous software version.
Sold states
Worldwide distribution: US (nationwide) to states of: CA, IL, NY, OH, and PA; and to countries of: Australia, Austria, Columbia, Egypt, France, Germany, India, Italy, Lithuania, Netherlands, and Switzerland.
Affected count
24
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0823-2019Don't want to check this manually?
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