MODEL 4041 - 4 Angled Pair Crc Surface Coil

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

510(k) Number

K890855 ↗

FDA Product Code

LNH

Models / Variants

Model 4041

4 Angled Pair Crc Surface Coil

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• Magnetic Resonance Diagnostic Accessory

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See all devices from Medical Advances, Inc. →

• What anatomical regions is the Model 4041 Surface Coil designed to improve imaging clarity for in MRI systems?

  The Model 4041 is a 4-angled pair surface coil configured as a specialized radiofrequency coil array. It is designed to enhance signal reception for specific anatomical regions to improve image clarity and diagnostic accuracy, though the exact regions are not specified in the data. Its angled design suggests it may be particularly useful for areas requiring precise, multi-directional signal capture, such as joints, extremities, or other localized regions where standard coils may not provide optimal resolution.

• Is the Model 4041 coil intended for single-use or reusable applications in MRI environments?

  The Model 4041 is explicitly labeled as intended for single-use in MRI environments. This designation aligns with common practices for surface coils to ensure hygiene and prevent cross-contamination, though facilities may follow sterile or non-sterile handling protocols based on their internal protocols.

• How should the Model 4041 coil be stored to maintain its performance, and are there any special handling instructions?

  While the data does not specify exact storage conditions, the Model 4041 coil should be stored in accordance with the manufacturer’s guidelines to preserve its performance. Since it is intended for single-use and part of MRI system accessories, it is likely sensitive to environmental factors like moisture, temperature, or physical damage. Always refer to the accompanying documentation or contact Medical Advances, Inc. for precise storage instructions.

• What regulatory pathway was followed for the FDA clearance of the Model 4041 coil, and what does this mean for its use?

  The Model 4041 coil received FDA 510(k) clearance (K890855) under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance falls under the Radiology specialty category and is classified as a Class II device. The pathway ensures compliance with FDA standards for safety and effectiveness, but it does not imply any specific clinical indication—only that it meets regulatory requirements for its intended use as described.