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31p/1h Dual Tuned Surface Coil 3t +2 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K102348

by Rapid Biomedical Gmbh

Identifiers

510(k) Number
K102348 FDA 510(k)
FDA Product Code
MOS FDA 510(k)
Models / Variants
31p/1h Dual Tuned Surface Coil 3t FDA 510(k)EUDAMED
23na/ 1h Dual Turned Surface Coil 3t FDA 510(k)EUDAMED
13c /1h Dual Turned Surface Coil 3t FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Magnetic Resonance, Specialty Coil designed for use in 3 Tesla (3T) MRI systems. The coils are dual-tuned surface coils optimized for specific nuclear magnetic resonance frequencies: phosphorus-31 (31P) and hydrogen-1 (1H), sodium-23 (23Na) and hydrogen-1 (1H), and carbon-13 (13C) and hydrogen-1 (1H). These coils enhance signal detection for specialized imaging applications, improving diagnostic accuracy in radiology.

The coils are intended for use in MRI environments and are supplied as reusable medical devices. They are classified as Class II devices under FDA regulations and comply with MDR (Medical Device Regulation) standards. Each coil variant is designed for specific imaging modalities, ensuring compatibility with 3T MRI systems. Storage and handling should follow manufacturer guidelines to maintain performance and sterility where applicable, though these coils are not sterile.

Frequently asked questions

What specific MRI frequencies are these surface coils optimized for, and how does that benefit imaging?

These coils are dual-tuned for specialized nuclear magnetic resonance frequencies: the 31P/1H coil targets phosphorus-31 and hydrogen-1, the 23Na/1H coil targets sodium-23 and hydrogen-1, and the 13C/1H coil targets carbon-13 and hydrogen-1. This dual-tuning enhances signal detection for phosphorus, sodium, and carbon imaging alongside standard hydrogen-1 (proton) imaging, improving diagnostic accuracy in metabolic and functional MRI studies, particularly in radiology applications.

Are these coils reusable, and if so, what maintenance or cleaning guidelines should be followed?

Yes, these coils are designed as reusable medical devices. While the manufacturer’s guidelines specify storage and handling to maintain performance, they do not require sterility for use. Proper cleaning and maintenance are critical to preserve coil integrity and signal quality, so adherence to Rapid Biomedical GmbH’s instructions is recommended to ensure longevity and reliable operation in 3T MRI systems.

What regulatory pathways have these coils undergone, and how does that affect their use in clinical settings?

These coils have undergone FDA 510(k) clearance (classified as Class II) and comply with the EU Medical Device Regulation (MDR). The abbreviated clearance type and substantial equivalence determination indicate they meet FDA standards for safety and effectiveness, while MDR compliance ensures alignment with European regulatory requirements. Clinicians can rely on these pathways to confirm the coils’ suitability for specialized MRI applications in radiology.

How do I determine which coil variant is best suited for my specific MRI application?

The choice depends on the nuclear magnetic resonance frequencies you need to target: use the 31P/1H coil for phosphorus imaging (e.g., metabolic studies), the 23Na/1H coil for sodium imaging (e.g., electrolyte assessment), or the 13C/1H coil for carbon imaging (e.g., metabolic tracing). All variants are compatible with 3T MRI systems, so consult your facility’s imaging protocols or Rapid Biomedical GmbH’s documentation to match the coil to your intended diagnostic application.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rapid Biomedical Gmbh

Sources (2)

  • FDA 510(k) K102348 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026