9 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 4, 2026
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
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: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 2, 2024
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 14, 2022
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
FDA Enforcement
Class II
·Terminated·CryoLife, Inc.·July 19, 2017
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
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026