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 table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071611000NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COILNeocoil2007-06-28MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856181003053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856181003053008561810030538561810030530856181003053

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA 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 table
Method

Regulatory Flags#

DUNS number
781155176
Device count
1
Serial number
true
Manufacturing date on label
true

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