dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213766 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)
These devices are Magnetic Resonance (MR) Specialty Coils designed for high-resolution imaging of small extremities. The dS FootAnkle 16-channel coils, dS HiRes HandWrist 16-channel coils, and ds Small Extremity 16-channel coils are optimized for 1.5T and 3.0T MRI systems, providing enhanced signal-to-noise ratio for detailed visualization of peripheral joints and limbs.
The coils are intended for use in radiology settings and are supplied as reusable, non-sterile components. They are compatible with MRI environments and must be stored according to manufacturer guidelines to maintain performance. Authorized under FDA 510K clearance, MDD, and MDR compliance, these coils are classified as Class II devices under regulation 892.1000.
Frequently asked questions
Are these coils designed for single-use or can they be reused in an MRI setting?
These coils are explicitly labeled as reusable components for MRI environments. Since they are not sterile and are intended for repeated use, proper cleaning and maintenance per the manufacturer’s guidelines are required to ensure performance and safety. They are not designed for single-use.
What types of MRI systems are these coils compatible with, and how does that affect imaging quality?
The coils are optimized for use with both 1.5T and 3.0T MRI systems, which are common field strengths in clinical imaging. Their 16-channel design enhances the signal-to-noise ratio, delivering high-resolution images of small extremities like feet, ankles, hands, wrists, and other peripheral joints. Compatibility with these field strengths ensures detailed visualization for diagnostic purposes.
How should these coils be stored to maintain their performance and longevity?
The coils must be stored according to manufacturer guidelines to preserve their performance. Since they are reusable and non-sterile, storage should be in a clean, dry environment away from direct sunlight, extreme temperatures, or magnetic interference. Proper handling and maintenance are critical to ensure consistent imaging quality over repeated use.
Are these coils approved for use in radiology departments globally, and what regulatory pathways apply?
Yes, these coils are authorized for use in radiology settings globally. They hold FDA 510(k) clearance in the U.S., MDD (Medical Device Directive) compliance in Europe, and MDR (Medical Device Regulation) compliance under EU regulations. They are classified as Class II devices under regulation 892.1000, indicating a moderate risk level requiring compliance with specific safety and performance standards.
What specific body parts are these coils intended to image, and why is high-resolution imaging important for those areas?
These coils are designed for high-resolution imaging of small extremities, including the foot, ankle, hand, wrist, and other peripheral joints. High-resolution imaging is critical in these areas because it allows radiologists to detect subtle abnormalities—such as soft tissue injuries, early signs of arthritis, or nerve compression—with greater clarity, improving diagnostic accuracy and patient care.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213766 | Class II | Active |
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Manufacturer
- Manufacturer
- Invivo Corporation
Sources (2)
- FDA 510(k) K213766 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026