31 results · 7ms · Sources: EU EUDAMED, US FDA

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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

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

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

Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·May 29, 2024

Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·May 29, 2024