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Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

by Philips Medical Systems Nederland B.V.

510(k) K251397

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

15 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK251397 Date4 Jun 2025ClearedStatusActive

Recalls

15 recalls · 15 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-3313-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3318-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3307-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3310-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3315-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3311-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3312-2026 FDA Class II initiated 28 Aug 2026

    When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.

  • 8 recalls, same reason

    • Ongoing Z-1968-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1965-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1958-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1964-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1954-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1962-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1969-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1961-2026 FDA Class II initiated 14 Apr 2026

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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