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: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
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