Identifiers
- 510(k) Number
- K151829 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 Atlas SPEEDER Header/Neck is a Coil, Magnetic Resonance, Specialty, designed for use in MRI systems to enhance imaging of the head and neck regions. It functions as a high-performance receiver coil, optimizing signal-to-noise ratio for detailed radiologic visualization in these anatomical areas.
This device is supplied as a reusable component for MRI systems and is intended for use in radiology settings. It is classified as a Class II medical device under FDA regulation 892.1000 and has received FDA 510(k) clearance (K151829). The coil is compatible with MRI environments and must adhere to strict electromagnetic interference and safety standards. No sterility or single-use specifications are indicated.
Frequently asked questions
What anatomical regions is the Atlas SPEEDER Header/Neck coil designed to enhance imaging for in MRI systems?
The Atlas SPEEDER Header/Neck coil is specifically designed to optimize imaging of the head and neck regions in MRI systems. By functioning as a high-performance receiver coil, it improves the signal-to-noise ratio, enabling clearer and more detailed visualization of these areas for diagnostic purposes.
Is the Atlas SPEEDER Header/Neck coil reusable or single-use, and what are the sterility requirements?
The Atlas SPEEDER Header/Neck coil is reusable and is not intended to be sterile. Since it is designed for MRI environments, it must be cleaned and maintained according to manufacturer guidelines to ensure electromagnetic compatibility and safety, but no sterility specifications are indicated.
What types of MRI systems is this coil compatible with, and how is it supplied?
The Atlas SPEEDER Header/Neck coil is designed for use in MRI systems and is supplied as a reusable component for integration into existing systems. It adheres to strict electromagnetic interference and safety standards required for MRI environments, ensuring compatibility with standard MRI platforms.
How many different models or variants of the Atlas SPEEDER Header/Neck coil are available, and how are they differentiated?
The device data lists multiple FEI (Final Establishment Identification) numbers, indicating that the Atlas SPEEDER Header/Neck coil may come in various models or configurations (e.g., different coil sizes or designs). These variants are likely tailored for different MRI system setups or patient sizes, though specific distinctions (e.g., size ranges) are not detailed in the provided data.
What regulatory pathway was followed for FDA clearance of the Atlas SPEEDER Header/Neck coil, and what does this mean for users?
The Atlas SPEEDER Header/Neck coil received FDA 510(k) clearance (K151829) through a Traditional 510(k) review, determined to be *substantially equivalent* to a predicate device. This means it was evaluated by the FDA’s Radiology (RA) Advisory Committee and deemed safe and effective for its intended use in MRI systems, ensuring compliance with FDA regulation 892.1000 for Class II devices.
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: Quality Electrodynamics Atlas Speeder Header/Neck, Atlas SPEEDER Header/Neck (K151829) — FDA 510(k) | Innolitics, PDF Microsoft Word - 510k Toshiba Atlas SPEEDER Head-Neck-510k Summary ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151829 | Class II | Active |
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Manufacturer
- Manufacturer
- Quality Electrodynamics Llc
- FDA Applicant
- Quality Electrodynamics, LLC
Sources (1)
- FDA 510(k) K151829 24 fields · synced Sep 19, 2026