1.5t 16ch Flex Speeder Large
FDA 510(k)EUDAMEDFDA UDIClass II (US FDA 510(k))
by Neocoil, Llc
Identity
- Trade Name
- 1.5T Receive-Only 16ch Flex SPEEDER Large EUDAMED1.5T 16ch Flex SPEEDER Large FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 16ch Flex SPEEDER Coils EUDAMEDThe NeoCoil 1.5T l6ch Flex SPEEDER is a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine. The system is compatible with 2D, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. FDA UDI
- Model / Reference
- 16ch Flex SPEEDER Coils EUDAMEDNC043200 EUDAMED16 FDA UDI
- Description
- The NeoCoil 1.5T l6ch Flex SPEEDER is a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine. The system is compatible with 2D, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003169 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932397U EUDAMED
- Direct Marketing DI
- 00856181003169 EUDAMED
- 510(k) Number
- FDA Product Code
- MOS FDA 510(k)FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The 1.5T 16-Channel Flex SpeedER Large Coil is a specialty magnetic resonance coil designed for high-performance imaging at 1.5 Tesla. It is engineered to enhance signal reception and spatial resolution in radiology applications, particularly for large anatomical regions requiring detailed visualization.
This coil is supplied as a reusable device intended for use in MRI-compatible environments. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and MDR authorization. The device is compatible with 1.5 Tesla MRI systems and is intended for professional use in radiology settings, adhering to strict sterility and safety protocols for repeated use.
Frequently asked questions
What is the primary purpose of the 1.5T 16CH FLEX SPEEDER LARGE coil, and how does it improve MRI imaging for large anatomical regions?
The 1.5T 16CH FLEX SPEEDER LARGE coil is designed to enhance signal reception and spatial resolution in MRI systems operating at 1.5 Tesla. Its 16-channel configuration allows for improved imaging of large anatomical regions by capturing clearer, more detailed visualizations, which is particularly useful in radiology for evaluating extensive areas like the torso or limbs.
Is this coil intended for single-use or reusable applications, and what sterility protocols should be followed?
This coil is explicitly designed for reusable applications in MRI-compatible environments. Since it is reusable, strict sterility and safety protocols must be followed between uses to ensure patient safety and device integrity, as outlined in the manufacturer’s guidelines for repeated-use medical devices.
What MRI system compatibility does this coil support, and is it limited to specific manufacturers?
The coil is compatible with 1.5 Tesla MRI systems but does not specify manufacturer exclusivity. Its design is optimized for high-performance imaging at this field strength, though final compatibility should be verified with your MRI system’s technical specifications to ensure proper integration and functionality.
How is the regulatory status of this device defined, and what does that mean for purchasing or clinical use?
The coil holds FDA 510K clearance and MDR authorization, classifying it as a Class II medical device under FDA regulations. This means it has undergone review by the FDA’s Radiology (RA) advisory committee and is deemed substantially equivalent to a predicate device, ensuring it meets established safety and performance standards for professional radiology use.
Are there multiple models or variations of this coil, and how can I identify the correct one for my needs?
While the provided data lists multiple FEI numbers (e.g., 3009529630, 3027339477), these are administrative identifiers tied to regulatory filings and do not indicate distinct physical variations of the coil itself. The 1.5T 16CH FLEX SPEEDER LARGE is the primary model described, so ensure your system’s requirements align with its design for large anatomical imaging before purchase.
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 | K121362 | Class II | Active |
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Manufacturer
- Manufacturer
- Neocoil, Llc
Sources (3)
- FDA 510(k) K121362 24 fields · synced Sep 18, 2026
- EUDAMED c32fcfa7-4ece-437b-94a7-8d6fe9f99a13 61 fields · synced May 19, 2026
- FDA UDI 2d9c5241-b5ed-4ec6-af07-82f98e36489c 34 fields · synced May 26, 2026