33 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Achieva 3.0T TX for PET Model Number (REF): 781479
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Achieva 1.5T Initial system Model Number (REF): 781178
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
SmartPath to dStream for 3.0T Model Number (REF): 782145
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
FDA Enforcement
Class II
·Terminated·Brainlab AG·November 11, 2015
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.
FDA Enforcement
Class II
·Terminated·Spectranetics Corp.·February 17, 2016
Ingenia 1.5T S Model Number (REF): 781347
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024