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Ingenia Elition and MR 7700 MR Systems

by Philips Medical Systems Nederland B.V. EUDAMED510(k)

Active European Union and United States

510(k) K230972

Overview

The Ingenia Elition and MR 7700 MR Systems are classified as Nuclear Magnetic Resonance Imaging Systems, designed for high-field magnetic resonance imaging. These devices generate detailed images of the human body’s internal structures using strong magnetic fields and radio waves, enabling diagnostic evaluation of soft tissues, organs, and musculoskeletal systems. They are engineered for advanced imaging capabilities, including multi-coil configurations and high-resolution scans, supporting a range of clinical applications in radiology.

These systems are intended for use in clinical radiology settings and are supplied as reusable medical equipment. They are not single-use and require proper maintenance and calibration to ensure MRI safety, including compliance with strict electromagnetic interference (EMI) and radiofrequency (RF) shielding standards. The devices are authorized under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with specific registration numbers and product codes (LNH) listed for regulatory tracking. Storage and handling must adhere to manufacturer guidelines to preserve performance and safety.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Recall ongoing. 19 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK230972 Date28 Apr 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls

19 recalls · 19 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-3313-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3311-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3317-2026 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.

  • 3 recalls, same reason

    • Ongoing Z-3242-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3243-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3239-2026 FDA Class II initiated 21 Aug 2026

    A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  • 2 recalls, same reason

    • Ongoing Z-1964-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1962-2026 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.

  • 4 recalls, same reason

    • Ongoing Z-1213-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1214-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1212-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1211-2026 FDA Class II initiated 3 Dec 2025

    The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

  • 3 recalls, same reason

    • Ongoing Z-2210-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2214-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2211-2025 FDA Class II initiated 30 Jun 2025

    The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

  • 4 recalls, same reason

    • Ongoing Z-1802-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1805-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1803-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1792-2025 FDA Class II initiated 13 May 2025

    Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Specification

EUDAMED · 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

Other devices from Philips Medical Systems Nederland B.V.

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Questions

  • What clinical applications are the Ingenia Elition and MR 7700 MR Systems primarily used for in radiology settings?

    The Ingenia Elition and MR 7700 MR Systems are designed for high-field magnetic resonance imaging to generate detailed images of soft tissues, organs, and the musculoskeletal system. These systems support advanced imaging capabilities, including high-resolution scans and multi-coil configurations, enabling diagnostic evaluations across a wide range of radiology applications such as musculoskeletal imaging, cardiac assessment, neurological studies, and abdominal/pelvic evaluations.

  • Are the Ingenia Elition and MR 7700 MR Systems reusable or single-use devices, and what does this mean for maintenance?

    The Ingenia Elition and MR 7700 MR Systems are reusable medical devices, meaning they are intended for repeated use in clinical settings. This requires strict adherence to manufacturer guidelines for maintenance, calibration, and safety protocols—including electromagnetic interference (EMI) and radiofrequency (RF) shielding—to ensure consistent performance and patient safety over time.

  • What regulatory pathways have been followed for the Ingenia Elition and MR 7700 MR Systems, and how does this affect procurement?

    The Ingenia Elition and MR 7700 MR Systems have been authorized under both the FDA’s 510(k) clearance process and the EU Medical Device Regulation (MDR). These pathways confirm their compliance with safety and performance standards in their respective markets. When procuring, buyers should verify the specific regulatory registration numbers (e.g., 3008156140) and product codes (LNH) to ensure alignment with local regulatory requirements.

  • How should storage and handling of the Ingenia Elition and MR 7700 MR Systems be managed to maintain performance and safety?

    Proper storage and handling of these systems are critical to preserve performance and ensure MRI safety. The manufacturer’s guidelines must be followed, including environmental controls (e.g., temperature, humidity), protection from physical damage, and adherence to electromagnetic shielding standards. Failure to comply could compromise imaging quality or pose risks to patients and staff.