Pediatric 16, A1.5T Tim Coil / Pediatric 16, A3T Tim Coil
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140998 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 Pediatric 16, A1.5T Tim Coil and Pediatric 16, A3T Tim Coil are specialized magnetic resonance coils designed for pediatric MRI imaging. These devices enhance signal reception in small patients, improving image quality and diagnostic accuracy for radiologic examinations in children.
Supplied as single-use or reusable components, these coils are intended for use in MRI systems operating at 1.5T and 3T field strengths. They are classified as Class II devices under FDA regulations and comply with the Medical Device Regulation (MDR). The coils require proper handling, storage, and maintenance to ensure MRI safety and performance, adhering to manufacturer guidelines for sterility and compatibility with pediatric imaging protocols.
Frequently asked questions
Are these coils designed for use with specific MRI field strengths, and if so, which ones?
Yes, the Pediatric 16, A1.5T Tim Coil and Pediatric 16, A3T Tim Coil are specifically designed for MRI systems operating at 1.5 Tesla (1.5T) and 3 Tesla (3T) field strengths, respectively. This ensures optimal signal reception for pediatric imaging at these common clinical strengths.
Can these coils be reused, or are they intended for single-use only?
The coils are supplied as both single-use and reusable components, depending on the configuration or model variant. The manufacturer’s guidelines must be followed to ensure proper handling, maintenance, and sterility—especially if reused—to maintain MRI safety and performance.
What regulatory pathways have these coils undergone, and which advisory committee was involved?
These coils were cleared via the FDA 510(k) pathway under a Traditional Review with the Radiology (RA) Advisory Committee. They are also compliant with the Medical Device Regulation (MDR) in the EU. The clearance was determined to be Substantially Equivalent (SE) to a predicate device.
How do these coils improve imaging for pediatric patients compared to standard coils?
The Pediatric 16 coils are specialized for small patients, enhancing signal reception and improving image clarity and diagnostic accuracy in pediatric MRI scans. Their design reduces artifacts and optimizes resolution, which is critical for accurate evaluations in children.
What storage or handling precautions should be taken to ensure proper functionality and safety?
The coils require proper handling, storage, and maintenance as outlined by the manufacturer to ensure MRI safety and performance. This includes adherence to sterility protocols (if applicable), protection from physical damage, and compatibility with pediatric imaging protocols to avoid interference or signal degradation.
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 | K140998 | Class II | Active |
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Manufacturer
- Manufacturer
- Quality Electrodynamics Llc
- FDA Applicant
- Quality Electrodynamics, LLC
Sources (2)
- FDA 510(k) K140998 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026