31p/1h Head Coil 3t +2 more models
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- 31P/1H Head Coil EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Head Coil EUDAMED31P/1H Head Coil FDA UDI
- Model / Reference
- 02000 EUDAMEDFDA UDI
- Description
- 31P/1H Head Coil FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260487680577 EUDAMEDFDA UDI
- Basic UDI-DI
- 426048768FAMHead_IIaUW EUDAMED
- Direct Marketing DI
- 04260487680577 EUDAMED
- FDA Product Code
- MOS FDA 510(k)FDA UDI
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The 31P/1H Head Coil 3T, 23Na/1H Head Coil 3T, and 13C/1H Head Coil 3T are specialty magnetic resonance coils designed for use in 3 Tesla MRI systems. These coils are tailored for high-resolution imaging of phosphorus-31, sodium-23, and carbon-13 nuclei in the head region, enabling advanced metabolic and biochemical studies.
These coils are intended for use in clinical and research MRI environments, supplied as reusable devices, and are classified as Class II medical devices under FDA regulations. They are compatible with 3 Tesla MRI systems and require proper handling and storage to maintain performance. Authorized under FDA 510K and MDR, they are regulated for safety and performance in radiology applications.
Frequently asked questions
What types of MRI systems are these coils compatible with and what specific nuclei do they target for imaging?
These coils—31P/1H Head Coil 3T, 23Na/1H Head Coil 3T, and 13C/1H Head Coil 3T—are designed exclusively for 3 Tesla MRI systems. They are tailored for high-resolution imaging of specific nuclei: phosphorus-31 (31P) for metabolic studies, sodium-23 (23Na) for biochemical assessments, and carbon-13 (13C) for specialized metabolic research. The 1H (proton) component in each coil enables simultaneous hydrogen imaging for anatomical reference, making them ideal for advanced clinical and research applications in radiology.
Are these coils reusable or single-use, and what maintenance or storage requirements should be followed?
These coils are reusable devices, intended for use in clinical and research MRI environments. Since they are not sterile, proper cleaning and handling protocols must be followed to maintain performance and prevent contamination. Storage should be in a clean, dry environment, away from sources of electromagnetic interference or physical damage, to preserve their functionality for repeated use.
How do I determine which coil model is right for my research or clinical application?
The choice depends on the nucleus you need to image: the 31P/1H Head Coil 3T is for phosphorus-31 studies (e.g., energy metabolism), the 23Na/1H Head Coil 3T for sodium-23 studies (e.g., cellular function), and the 13C/1H Head Coil 3T for carbon-13 studies (e.g., metabolic tracing). All three include a proton (1H) channel for anatomical alignment. Confirm compatibility with your 3T MRI system’s software and consult your manufacturer’s documentation for specific technical requirements.
What regulatory pathways have these coils undergone, and how does that affect their use in clinical or research settings?
These coils are authorized under FDA 510K clearance and the EU Medical Device Regulation (MDR), confirming they meet safety and performance standards for Class II medical devices. The FDA’s Radiology (RA) Advisory Committee reviewed their substantial equivalence, and they are classified under product code MOS (Magnetic Resonance Coils). This regulatory clearance ensures they are suitable for both clinical and research MRI environments, provided they are used as intended and maintained per manufacturer guidelines.
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
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 | K102748 | Class II | Active |
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Manufacturer
- Manufacturer
- Rapid Biomedical Gmbh
Sources (3)
- FDA 510(k) K102748 24 fields · synced Oct 6, 2026
- FDA UDI e3cdacc2-7c6e-40f5-b5de-d38bf57978f0 35 fields · synced May 30, 2026
- EUDAMED 4e24f7a9-2e86-4d1d-93e2-3a77cab61683 61 fields · synced Jul 29, 2026