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1.5T HD 8Ch Shoulder Coil
EUDAMEDFDA UDIClass I (EU MDR)
Ref NC008901Model 8Ch Shoulder Coil
by NeoCoil, LLC
Identity
- Trade Name
- 1.5T HD 8Ch Shoulder Coil EUDAMED1.5T 8ch Shoulder Coil FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 8Ch Shoulder Coil EUDAMEDThe NeoCoil 1 ST 8-Channel Shoulder Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its unique eight channel layout and a larger field-of-view due to the antenna layout. FDA UDI
- Model / Reference
- 8Ch Shoulder Coil EUDAMEDNC008901 EUDAMED04 FDA UDI
- Description
- The NeoCoil 1 ST 8-Channel Shoulder Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its unique eight channel layout and a larger field-of-view due to the antenna layout. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003046 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932417F EUDAMED
- Direct Marketing DI
- 00856181003046 EUDAMED
- 510(k) Number
- K071311 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: MRI system coil, radio-frequency
1.5T HD 8Ch Shoulder Coil by Neocoil, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850028932417F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NeoCoil, LLC
- EUDAMED SRN
- US-MF-000027128
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6942c211-54f7-4eeb-b65c-17bb93a7fd3e 61 fields · synced Jun 18, 2026
- FDA UDI 8bb733ca-8440-4ad2-84dc-02262603ff2a 34 fields · synced May 30, 2026