Achieva 1.5T, 3.0T and Intera 1.5T MR Systems

• • Ongoing Z-3232-2026 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.

• • Ongoing Z-1951-2026 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.

510(k) Number

K190461 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Azurion upgrade to R4

  Class IIb

  CE/MDR

• Marlin 1.5T

  Class IIb

  CE/MDR 2243595CE01 Active Valid to May 2030

• Zenition 30

  Class II

  FDA 510(k) K254205 Active Cleared 7 Aug 2026

• dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T

  Class II

  FDA 510(k) K262330 Active Cleared 30 Jul 2026

• dS FootAnkle 16Ch 1.5T

  Class II

  FDA 510(k) K262294 Active Cleared 24 Jul 2026

• Multimodality Simulation Workspace (MM Sim) Upgrade

  Class IIb

  CE/MDR GUDID on market

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

• What types of clinical settings are these MRI systems designed for, and why is that important?

  The Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems are specifically designed for use in radiology departments and clinical imaging settings. This is important because these environments require specialized infrastructure, such as proper shielding and patient screening protocols, to ensure safe operation of high-field MRI systems. The systems are optimized for detailed imaging of soft tissues, organs, and musculoskeletal systems, making them ideal for diagnostic evaluations in controlled clinical environments.

• Are these MRI systems reusable, and what does that mean for maintenance and safety protocols?

  Yes, these MRI systems are reusable medical equipment. This means they are built to withstand repeated use and require regular maintenance to ensure optimal performance and safety. Since they operate at strong magnetic fields (1.5 Tesla and 3.0 Tesla), strict adherence to MRI safety protocols—such as shielding, patient screening for metallic implants, and proper handling—is essential to prevent hazards like projectile forces or interference with implanted devices.

• What field strengths are available, and how might that affect imaging quality or clinical applications?

  The Achieva and Intera systems are available in configurations with field strengths of 1.5 Tesla and 3.0 Tesla. Higher field strengths like 3.0T generally provide superior image resolution and contrast, which can enhance the visualization of soft tissues, organs, and fine anatomical details. This makes the 3.0T model particularly useful for specialized applications like cardiac, neurological, or musculoskeletal imaging where detailed imaging is critical. The 1.5T systems offer a balance between image quality and accessibility, making them versatile for broader clinical use.

• How do I determine if a specific model or configuration is right for my facility?

  The choice between the Achieva (1.5T/3.0T) and Intera (1.5T) models depends on your facility’s clinical needs, budget, and space constraints. The Achieva 3.0T is ideal for advanced imaging requiring high resolution, while the Achieva 1.5T and Intera 1.5T offer reliable performance for general radiology applications. Consulting with Philips Medical Systems or a radiology specialist can help assess compatibility with your workflow, patient volume, and existing infrastructure—such as shielding requirements and room dimensions—to ensure optimal integration.