4 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
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