dS Base 1.5T - dS HeadNeck 1.5T

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K254190 ↗

FDA Product Code

MOS

Models / Variants

dS Base 1.5T

dS Base 3.0T

dS Head 1.5T

dS Head 3.0T

dS HeadNeck 1.5T

dS HeadNeck 3.0T

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. →

• Are these coils designed for single-use or reusable applications in MRI environments?

  The dS series coils are explicitly designed as reusable devices for MRI environments. Since they are intended for repeated use in radiology applications, proper cleaning, maintenance, and storage protocols must be followed to ensure performance, safety, and compliance with MRI safety standards for their respective field strengths (1.5T and 3.0T).

• What anatomical regions are these coils optimized for, and how do the field strengths (1.5T and 3.0T) affect their use?

  The dS coils are tailored for specific anatomical regions: base, head, and head-neck. The 1.5T and 3.0T variants are optimized for high-field MRI systems, with the higher field strength (3.0T) providing enhanced signal reception and improved image quality for these regions. The choice between 1.5T and 3.0T depends on the clinical workflow and the specific diagnostic requirements of the imaging center.

• How should these coils be stored to maintain their performance and compatibility with Philips MRI systems?

  The coils must be stored and handled according to the manufacturer’s guidelines to preserve their performance and sterility where applicable. Since they are reusable and designed for MRI environments, proper storage conditions—such as avoiding exposure to moisture, extreme temperatures, or physical damage—are critical. Additionally, compatibility with Philips MRI systems is model-specific, so adherence to the manufacturer’s instructions ensures optimal functionality and safety.

• What regulatory pathways have these coils undergone, and how does this impact their use in clinical settings?

  The dS coils are authorized under both FDA 510K and MDR (Medical Device Regulation) pathways, confirming their compliance with U.S. and European regulatory standards. This authorization ensures they meet safety and performance requirements for specialty MRI coils in radiology. Clinicians and facilities should refer to the manufacturer’s documentation for specific regulatory details and safety guidelines, particularly regarding MRI safety standards for their respective field strengths.

• Are there different models available, and how do I determine which one is best suited for my MRI system?

  Yes, the dS series includes six distinct models: dS Base (1.5T and 3.0T), dS Head (1.5T and 3.0T), and dS HeadNeck (1.5T and 3.0T). Each model is designed for compatibility with Philips MRI systems and optimized for specific anatomical regions. To select the appropriate model, consult your Philips MRI system’s documentation or contact Philips Medical Systems for guidance on model-specific compatibility and clinical applications.