40 results
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8ms
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Sources: EU EUDAMED, US FDA
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
FDA Enforcement
Class II
·Ongoing·Philips North America·November 22, 2023
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 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
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 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
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
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 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
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 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
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
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
Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 21, 2018
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Philips Spectral CT on Rails. Model Number: 728334.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·April 22, 2026
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
FDA Enforcement
Class II
·Ongoing·Philips North America·November 22, 2023
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
FDA Enforcement
Class II
·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 17, 2024
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021