5 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 8, 2019
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