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Achieva - and MR 5300 MR Systems

by Philips Medical Systems Nederland B.V.

510(k) K251808

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

19 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251808↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK251808 Date11 Jul 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

19 recalls · 19 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-3309-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3312-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3314-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3311-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3310-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3318-2026 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.

  • 6 recalls, same reason

    • Ongoing Z-3243-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3238-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3235-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3239-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3237-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3241-2026 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.

  • 6 recalls, same reason

    • Ongoing Z-1961-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1958-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1967-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1959-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1963-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1954-2026 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.

    • Ongoing Z-1204-2026 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).

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LNH
Models / Variants
and MR 5300 MR Systems
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X, Achieva, Intera, and MR 5300 are 1.5-tesla and 3.0-tesla magnetic resonance (MR) imaging systems designed for high-resolution anatomical and functional imaging. These devices incorporate advanced gradient and radiofrequency technology to deliver detailed cross-sectional images of soft tissues, organs, and vascular structures, supporting diagnostic evaluations in radiology and clinical research.

These MR systems are supplied as reusable, non-sterile medical devices intended for use in hospital or clinical imaging centers. They are regulated under FDA 510(k) clearance (K251808) and EU MDR compliance, with magnetic field strengths of 1.5T and 3.0T requiring strict adherence to MRI safety protocols. Storage and operational environments must comply with manufacturer guidelines to ensure optimal performance and patient safety. No single-use or sterile variants are specified in the regulatory data.

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these MRI systems designed for single-use or reusable in clinical settings? Why does this matter?

    These MRI systems (Ingenia 1.5T, Ingenia 3.0T, Achieva, etc.) are explicitly described as reusable, non-sterile devices. This matters because reusable systems require strict maintenance protocols, cleaning procedures, and regular servicing to ensure patient safety and imaging accuracy over time. Single-use devices are not applicable here, as the regulatory data does not mention any sterile or disposable variants.

  • What magnetic field strengths are available, and how does this affect their use in clinical settings?

    The systems listed include 1.5-tesla (T) and 3.0-tesla (T) magnetic field strengths, which enable high-resolution imaging of soft tissues, organs, and vascular structures. The higher field strength (3.0T) provides superior detail but requires strict MRI safety protocols due to increased magnetic forces and radiofrequency exposure risks. Clinicians must ensure proper screening of patients and staff for metallic implants or ferromagnetic materials before use.

  • How are these MRI systems regulated, and what does that mean for purchasing or implementing them?

    These devices are regulated under FDA 510(k) clearance (K251808) and comply with EU MDR (Medical Device Regulation). The FDA clearance indicates they are deemed *substantially equivalent* to a predicate device, while MDR compliance ensures they meet EU safety, performance, and traceability standards. Buyers should verify local regulatory requirements and ensure their facility adheres to MRI safety guidelines, as these systems operate at high magnetic fields (1.5T/3.0T) that pose risks if not managed properly.

  • What types of imaging applications are these systems primarily intended for, based on their design?

    These MRI systems are designed for high-resolution anatomical and functional imaging, particularly excelling in visualizing soft tissues, organs, and vascular structures. Their advanced gradient and radiofrequency technology supports diagnostic evaluations in radiology and clinical research, making them suitable for applications like musculoskeletal imaging, cardiac studies, neurological assessments, and vascular diagnostics. The specific models (e.g., Ingenia Elition X) may offer enhanced features for specialized workflows, but the core purpose remains detailed cross-sectional imaging.

  • Are there any special storage or environmental requirements for these MRI systems?

    While the data doesn’t specify exact storage conditions, the high magnetic field strengths (1.5T/3.0T) and advanced technology imply that these systems require controlled environments to prevent interference, overheating, or damage. Manufacturer guidelines (not detailed here) likely include temperature, humidity, and electromagnetic shielding considerations. Additionally, operational areas must comply with MRI safety protocols to mitigate risks from ferromagnetic objects or incompatible materials in the vicinity.