P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163661 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)
The P-140-Flex Coil, Na-140-Flex Coil, and C-140-Flex Coil are classified as Coil, Magnetic Resonance, Specialty (product code MOS). These devices are designed as diagnostic extensions for use with Philips 3.0 Tesla Magnetic Resonance (MR) Systems, enabling signal reception and imaging in specific anatomical regions during MRI procedures.
These coils are supplied as single-use or reusable components, depending on the model, and are intended for use within MRI-compatible environments. They are regulated under FDA 510(k) clearance (K163661) and the EU Medical Device Regulation (MDR), adhering to Class II – Special Controls. Each coil variant is tailored for compatibility with Philips 3.0 T MR Systems, with no additional sterility requirements specified beyond standard MRI facility protocols.
Frequently asked questions
Are these coils reusable or single-use, and how should I determine which model fits my needs?
The P-140-Flex, Na-140-Flex, and C-140-Flex coils are supplied as either single-use or reusable, depending on the specific model variant. The data does not specify which models are reusable or single-use, so you should refer to the manufacturer’s instructions or contact Rapid Biomedical GmbH directly for clarification. These coils are designed exclusively for use with Philips 3.0 Tesla MR Systems, so compatibility is determined by the coil’s intended anatomical application and your MRI setup.
Do these coils require any special handling or storage conditions beyond standard MRI facility protocols?
The P-140-Flex, Na-140-Flex, and C-140-Flex coils do not have additional sterility requirements beyond what is standard for MRI facility protocols. However, since they are intended for use in MRI-compatible environments, proper storage should ensure they remain free from contamination, moisture, or physical damage. Always follow the manufacturer’s guidelines for handling and storage to maintain performance and safety.
What regulatory pathways have these coils undergone, and how does that affect their use in clinical settings?
These coils are regulated under both the FDA 510(k) pathway (with clearance K163661) and the EU Medical Device Regulation (MDR), classified as Class II – Special Controls. The FDA clearance indicates they are deemed substantially equivalent to a predicate device, while MDR compliance ensures they meet EU safety and performance standards. Clinically, this means they have undergone review by regulatory bodies for safety and effectiveness, but the specific indications or intended uses are determined by the product code (MOS) and manufacturer’s instructions, not the regulatory status itself.
How do I know which of these coils is best suited for my specific anatomical region during MRI procedures?
The P-140-Flex, Na-140-Flex, and C-140-Flex coils are specialty MRI coils designed for signal reception in specific anatomical regions during MRI procedures on Philips 3.0 Tesla systems. The exact anatomical focus for each variant isn’t detailed in the data, so you should consult the manufacturer’s documentation or contact Rapid Biomedical GmbH for guidance. They can provide details on which coil aligns with your imaging needs, such as head, neck, or other targeted regions.
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: P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil (K163661) — FDA 510 ..., K163661 FDA 510 (k) - P-140-Flex Coil | Rapid Biomedical GmbH, RAPID Biomedical - MR Coils - Made to Measure
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 | K163661 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rapid Biomedical Gmbh
Sources (2)
- FDA 510(k) K163661 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026