BEUDAMED
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    Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

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

    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

    Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.

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

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

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

    Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

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

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

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

    Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

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

    Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

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

    Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

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

    Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

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

    Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

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

    Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

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

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

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

    Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

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

    Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.

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

    Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

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

    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

    Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.

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

    Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

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