8 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 14, 2022
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
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
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
FDA Enforcement
Class II
·Ongoing·Philips North America·August 16, 2023
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
FDA Enforcement
Class II
·Ongoing·Philips North America·August 16, 2023
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 2, 2024