BEUDAMED
    4 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 28, 2025

    Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 6, 2025

    Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026