5 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 16, 2014
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 6, 2013
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 1, 2021
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 29, 2015
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 12, 2014