1.5T 16ch Shoulder Coil (System) - The 16ch Shoulder Coil is a receive-only phased - NEOCOIL, LLC

Duns Number:781155176

Device Description: The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal- 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.

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More Product Details

Catalog Number

NC143001

Brand Name

1.5T 16ch Shoulder Coil (System)

Version/Model Number

93

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K201101

Product Code Details

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Device Record Status

Public Device Record Key

33dab357-b2d1-4132-9408-e8ded3d0c3b3

Public Version Date

December 31, 2020

Public Version Number

2

DI Record Publish Date

September 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEOCOIL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 75