4 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 4, 2026
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024