6 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Achieva XR Product Numbers: (1) 781153, (2) 781253;
FDA Enforcement
Class II
·Ongoing·Philips North America·June 18, 2025
Achieva XR. Model (REF) Numbers 781153, 781253.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Achieva XR, Magnetic Resonance System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 24, 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