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1.5T 16ch Shoulder Coil
EUDAMEDFDA UDIClass I (EU MDR)
Ref NC143203Model 16ch Shoulder Coil
by NeoCoil, LLC
Identity
- Trade Name
- 1.5T 16ch Shoulder Coil EUDAMED1.5T 16ch Shoulder Coil (Device) FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 16ch Shoulder Coil EUDAMEDThe 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform coverage of the shoulder anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil’s system cable. The amplified signals are processed into tomographic images of the shoulder anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy. During a shoulder MRI exam, the patient lays in the supine position on the MRI scanner table. The rigid Posterior Array is positioned beneath the patient’s affected shoulder. The flexible Anterior Array is positioned on top of the patient’s affected shoulder. The 16ch Shoulder Posterior Housing Pad and 16ch Shoulder Pad provided with the coil promote patient comfort and facilitate patient positioning. Table Straps provided with the MRI scanner may be used to minimize unintended patient movement during the exam. FDA UDI
- Model / Reference
- 16ch Shoulder Coil EUDAMEDNC143203 EUDAMED91 FDA UDI
- Description
- The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform coverage of the shoulder anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil’s system cable. The amplified signals are processed into tomographic images of the shoulder anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy. During a shoulder MRI exam, the patient lays in the supine position on the MRI scanner table. The rigid Posterior Array is positioned beneath the patient’s affected shoulder. The flexible Anterior Array is positioned on top of the patient’s affected shoulder. The 16ch Shoulder Posterior Housing Pad and 16ch Shoulder Pad provided with the coil promote patient comfort and facilitate patient positioning. Table Straps provided with the MRI scanner may be used to minimize unintended patient movement during the exam. FDA UDI
Identifiers
- Catalog Number
- NC143203 FDA UDI
- Primary DI / UDI-DI
- 00856181003916 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932377Q EUDAMED
- Direct Marketing DI
- 00856181003916 EUDAMED
- 510(k) Number
- K201101 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 16ch 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 | 0850028932377Q | 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 08c73bd2-9f2c-4ee7-a49f-7f9cb2cc160b 61 fields · synced Jul 20, 2026
- FDA UDI 5aa8ad10-9e4c-4d72-b8a5-30d7d8ab84af 35 fields · synced May 29, 2026