3T Receive-Only 16ch Flex SPEEDER Medium
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
by NeoCoil, LLC
Identity
- Trade Name
- 3T Receive-Only 16ch Flex SPEEDER Medium EUDAMED3T 16ch Flex SPEEDER Medium FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 16ch Flex SPEEDER Coils EUDAMEDThe NeoCoil 3T l6ch Flex SPEEDER Coils are 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 20, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. FDA UDI
- Model / Reference
- 16ch Flex SPEEDER Coils EUDAMEDNC045200 EUDAMED25 FDA UDI
- Description
- The NeoCoil 3T l6ch Flex SPEEDER Coils are 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 20, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003251 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932397U EUDAMED
- Direct Marketing DI
- 00856181003251 EUDAMED
- 510(k) Number
- K141832 FDA UDI
- FDA Product Code
- MOS 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 UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- 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
Category: MRI system coil, radio-frequency
3T Receive-Only 16ch Flex SPEEDER Medium by Neocoil, Llc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141832 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850028932397U | Class I | Active |
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Manufacturer
- Manufacturer
- NeoCoil, LLC
- EUDAMED SRN
- US-MF-000027128
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 332d25fa-eda3-47f9-9cd0-c98898a3cb34 61 fields · synced Jul 30, 2026
- FDA UDI ca686b68-7329-42c6-8957-46831640e13e 34 fields · synced May 29, 2026
- FDA 510(k) K141832 1 fields · synced May 18, 2026