Address:N27 W23910A PAUL RD.,Pewaukee,WI,53072,US
Device Description : The NeoCoil 3.OT 6-Channel Carotid Array Coil is a multi-element phased array re The NeoCoil 3.OT 6-Channel Carotid Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the carotid arteries andassociated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its operating field strength of 3.0T, and a larger field-of-view due to the antenna layout.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 3.OT 32-Channel Torso Array Coil is a multi-element phased array rec The NeoCoil 3.OT 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE S.OT HD Series MR System (K052293)
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 3.OT 32-Channel Torso Array Coil is a multi-element phased array rec The NeoCoil 3.OT 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest,abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posteriorarray contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE S.OT HD Series MR System (K052293)
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 1 ST 8-Channel Shoulder Array Coil is a multi-element phased array r The NeoCoil 1 ST 8-Channel Shoulder Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its unique eight channel layout and a larger field-of-view due to the antenna layout.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 3.OT 8-Channel Shoulder Array Coil is a multi-element phased arrayre 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.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for i The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for i The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for i The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for i The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for i The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes