3T 8ch Shoulder Coil
- Primary DI
- 00856181003053
- Brand
- 3T 8ch Shoulder Coil
- Company
- NEOCOIL, LLC
- Model
- 05
- Device description
- The NeoCoil 3.OT 8-Channel Shoulder Array Coil is a multi-element phased arrayreceive only coil used for obtaining diagnostic images of the shoulder in MagneticResonance Imaging Systems. Compared to predicate devices, the submitteddevice offers easier patient setup and greater SNR due to its compatibility with3.OT MRI scanners.The submitted device consists of semi-flexible foam covered housing, consistingof eight antennas. The antennas are uniquely positioned with the appropriateoverlap to cancel out mutual coupling effects from adjacent antennas ordecoupled from an adjacent antenna using a transformer. Pre-amplifierdecoupling reduces any remaining decoupling between the antennas.The coil is held in place over the imaging area via a cross body strap. A systeminterface cable connects to the coil at the top of the housing. The flexible foamcovered housing along with the body strap enable the proper positioning on thepatient before laying down and holds the coil in place while scanning is beingperformed.To ensure safety, each antenna is equipped with active and passive transmitdecoupling circuits. Active decoupling is achieved via diodes that receive signalsfrom the scanner to turn the coil to a high impedance state during system RFtransmit. Crossed diodes are installed on each antenna acting as passiveswitches. These passive switches provide additional safety in case the activecircuitry does not receive signal from the scanner.
- Published
- 2017-03-16
- 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 |
|---|---|
| K071611 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00856181003053 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00856181003053 | 00856181003053 | 856181003053 | 0856181003053 |
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
- Manufacturing date on label
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 00850028932537 | 1.5T 16ch Breast Coil | 53 | NC149229 | 2025-11-18 |
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| 00850028932506 | 32ch AIR Open Coil Suite, 1.5T | 50 | NC139021 | 2023-01-27 |
| 00856181003930 | 1.5T 16ch Shoulder Coil (System) | 93 | NC143001 | 2020-09-09 |
| 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 |
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