dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212864 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 dS TorsoCardiac 1.5T, dS MSK S 1.5T, and dS MSK M 1.5T are specialty magnetic resonance coils designed for high-resolution imaging. These devices enhance diagnostic accuracy by providing detailed visualization of cardiac and musculoskeletal structures at a 1.5 Tesla magnetic field strength, supporting radiology applications.
These coils are supplied as reusable medical devices intended for use in MRI environments. They are compatible with 1.5T MRI systems and require proper handling, storage, and maintenance to ensure MRI safety and performance. Authorized under FDA 510K and MDR regulations, they are classified as Class II devices under the Medical Specialty Coil category.
Frequently asked questions
Are these coils designed for single-use or can they be reused in an MRI environment?
These coils are explicitly designed as reusable medical devices for use in MRI environments. Since they are intended for repeated use, proper handling, storage, and maintenance are required to ensure MRI safety and optimal performance. Reuse is permitted under the conditions outlined in the manufacturer’s instructions.
What types of anatomical structures are these coils optimized for imaging?
The dS TorsoCardiac 1.5T coil is specialized for high-resolution imaging of cardiac structures, while the dS MSK S 1.5T and dS MSK M 1.5T coils are designed for musculoskeletal (MSK) applications, including soft tissues, joints, and bones. Their 1.5 Tesla magnetic field strength enhances diagnostic clarity for these specific areas.
How do I determine which coil model is best suited for my MRI system?
All three coils (dS TorsoCardiac 1.5T, dS MSK S 1.5T, and dS MSK M 1.5T) are compatible with 1.5T MRI systems. The choice depends on the anatomical focus: the TorsoCardiac is for cardiac imaging, while the MSK S and MSK M differ in size (small vs. medium) to accommodate varying patient anatomies. Consult your MRI system’s documentation and manufacturer guidelines to confirm compatibility.
What regulatory pathways have these coils undergone, and what does that mean for their use?
These coils are authorized under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), confirming they meet safety and performance standards for their intended use. As Class II devices in the *Medical Specialty Coil* category, they undergo rigorous review by the FDA’s Radiology Advisory Committee (RA) to ensure compliance with MRI safety and diagnostic accuracy requirements. This means they are approved for use in clinical settings following manufacturer instructions.
Are there specific storage or maintenance requirements for these reusable coils?
Since these coils are reusable, they must be stored and maintained according to the manufacturer’s guidelines to preserve MRI safety and performance. This typically includes cleaning protocols, proper handling to avoid damage, and periodic inspections to ensure functionality. Failure to adhere to these instructions could compromise imaging quality or pose risks in the MRI environment.
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 | K212864 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
Sources (2)
- FDA 510(k) K212864 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026