1.5T 16ch Shoulder Coil (System)
- Primary DI
- 00856181003930
- Brand
- 1.5T 16ch Shoulder Coil (System)
- Company
- NEOCOIL, LLC
- Model
- 93
- Catalog number
- NC143001
- Device 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.
- Published
- 2020-09-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| MOS | Coil, Magnetic Resonance, Specialty |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | Radiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K201101 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00856181003930 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00856181003930 | 00856181003930 | 856181003930 | 0856181003930 |
GMDN Terms#
| Term | Definition |
|---|---|
| MRI system coil, radio-frequency | A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 781155176
- Device count
- 1
- Serial number
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850028932537 | 1.5T 16ch Breast Coil | 53 | NC149229 | 2025-11-18 |
| 00850028932490 | 32ch AIR Open Coil Suite, 3.0T | 49 | NC139020 | 2023-01-27 |
| 00850028932506 | 32ch AIR Open Coil Suite, 1.5T | 50 | NC139021 | 2023-01-27 |
| 00856181003923 | 3.0T 16ch Shoulder Coil (System) | 92 | NC143000 | 2020-07-17 |
| 00856181003893 | 1.5T 16Ch Breast Coil | 89 | M7006PH | 2019-06-10 |
| 00856181003824 | 3.0T 16ch Breast Coil | 82 | M7006PA | 2018-04-26 |
| 00850028932452 | 3T 16ch Breast Coil | 45 | NC149209 | 2023-03-23 |
| 00850028932469 | 1.5T 16ch Breast Coil | 46 | NC149229 | 2023-03-23 |
| 00850028932513 | Biopsy Grid Assembly, Pack, Breast Coil | 51 | NC149444 | 2023-03-23 |
| 00850028932520 | Drape Pack, Biopsy, Breast Coil | 52 | NC149475 | 2023-03-23 |
| 00850028932254 | 3.0T AIR Open Head Neck Posterior 9ch | 25 | NC139200 | 2023-01-27 |
| 00850028932261 | 3.0T AIR Open Neck Chest Anterior 7ch | 26 | NC139201 | 2023-01-27 |
| 00850028932278 | 3.0T AIR Open Head Anterior 16ch | 27 | NC139202 | 2023-01-27 |
| 00850028932285 | 1.5T AIR Open Head Neck Posterior 9ch | 28 | NC139203 | 2023-01-27 |
| 00850028932292 | 1.5T AIR Open Neck Chest Anterior 7ch | 29 | NC139204 | 2023-01-27 |
| 00850028932308 | 1.5T AIR Open Head Anterior 16ch | 30 | NC139205 | 2023-01-27 |
| 00856181003312 | ECG CT Gating Device | 31 | 2017-03-21 | |
| 00856181003329 | ECG CT Gating Receiver | 32 | 2017-03-21 | |
| 00856181003336 | ECG CT Gating Cable | 33 | 2017-03-21 | |
| 00856181003916 | 1.5T 16ch Shoulder Coil (Device) | 91 | NC143203 | 2021-01-04 |
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| 00850083516000 | Nuzzle Body Array, 1.5T | Inkspace Imaging, Inc. | MOS | 2026-04-21 |
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| 00860008041371 | Snuggle Pediatric Array – PH 3T (Dino) | Inkspace Imaging, Inc. | MOS | 2026-04-21 |
| 00860008041395 | Nuzzle Body Array – PH 3T (Whimsical) | Inkspace Imaging, Inc. | MOS | 2026-04-21 |
| 00884838130548 | DUNLEE | Philips Medical Systems Nederland B.V. | MOS | 2026-04-03 |
| 00884838130555 | DUNLEE | Philips Medical Systems Nederland B.V. | MOS | 2026-04-03 |
| 00884838130562 | DUNLEE | Philips Medical Systems Nederland B.V. | MOS | 2026-04-03 |
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| 00884838130623 | DUNLEE | Philips Medical Systems Nederland B.V. | MOS | 2026-04-03 |
| 00884838132597 | DUNLEE | Philips Medical Systems Nederland B.V. | MOS | 2026-04-03 |
| 00884838132603 | DUNLEE | Philips Medical Systems Nederland B.V. | MOS | 2026-04-03 |
| 00884838093089 | MRI Coils | Philips Ds North America LLC | MOS | 2025-10-01 |
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| 00884838098510 | MRI Coils | Philips Ds North America LLC | MOS | 2025-10-01 |
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| 00884838118997 | MR Coils | Philips Medical Systems Nederland B.V. | MOS | 2025-10-01 |
| 00884838119000 | MR Coils | Philips Medical Systems Nederland B.V. | MOS | 2025-10-01 |
| 00884838108080 | MRI Coils | Philips Ds North America LLC | MOS | 2025-09-30 |
| 00884838111172 | DUNLEE | Philips Medical Systems Nederland B.V. | MOS | 2025-09-30 |