31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213480 FDA 510(k)
- FDA Product Code
- MOS FDA 510(k)
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 dual-tuned spectroscopy and imaging of the brain. It enables simultaneous acquisition of proton (1H) and one additional nucleus—either phosphorus-31 (31P), sodium-23 (23Na), or carbon-13 (13C)—for advanced metabolic and functional studies in magnetic resonance imaging (MRI).
The coil is intended for use with 3.0 Tesla (3T) MRI systems from Philips, Siemens, or GE and features a 26 cm inner diameter with a sliding mechanism for patient positioning. Supplied as a reusable, non-sterile component, it requires compatibility with the MRI system’s hardware for decoupled experiments. Authorized under FDA 510(k) clearance (K213480) and MDR compliance, it is classified as a Class II medical device.
Frequently asked questions
What types of MRI systems is this coil compatible with, and what specific features does it offer for brain imaging?
This coil is designed for use with 3.0 Tesla (3T) MRI systems from Philips, Siemens, and GE. It enables dual-tuned spectroscopy and imaging of the brain, allowing simultaneous acquisition of proton (1H) signals alongside either phosphorus-31 (31P), sodium-23 (23Na), or carbon-13 (13C). This dual-tuning capability supports advanced metabolic and functional studies, making it ideal for research and specialized clinical applications requiring multi-nucleus imaging.
Is this coil reusable, and if so, what considerations should be taken into account for its use?
Yes, this coil is supplied as a reusable, non-sterile component. Since it is not sterile, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and hygiene. Additionally, compatibility with the MRI system’s hardware is required for decoupled experiments, so users should verify system-specific requirements before use.
What is the inner diameter of the coil, and how does the sliding mechanism affect patient positioning?
The coil has a 26 cm inner diameter, which accommodates most adult head sizes. The sliding mechanism is included to facilitate easy and precise patient positioning within the coil, ensuring consistent and comfortable placement for imaging sessions.
What regulatory pathways has this device undergone, and what does that mean for its use?
This coil has undergone FDA 510(k) clearance (K213480) and is compliant with the EU’s Medical Device Regulation (MDR). The FDA clearance indicates it is deemed substantially equivalent to a legally marketed device, while MDR compliance ensures it meets EU safety, performance, and regulatory standards. These pathways confirm its suitability for clinical and research use in the respective regions.
Are there different models of this coil, and if so, how do they differ?
This coil is available in three variants: the 31P/1H Head Coil, the 23Na/1H Head Coil, and the 13C/1H Head Coil. The primary difference lies in the additional nucleus each coil is tuned to detect alongside proton (1H) signals—phosphorus-31, sodium-23, or carbon-13—allowing researchers to tailor the coil to specific metabolic or functional imaging needs.
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. Sources consulted: RAPID Biomedical - MR Coils - Made to Measure, 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil (K213480) — FDA ..., Dual Tuned Head Coils 3 T - RAPID Biomedical, 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil (K213480)
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213480 | Class II | Active |
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Manufacturer
- Manufacturer
- Rapid Biomedical Gmbh
Sources (2)
- FDA 510(k) K213480 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026