Address:N27 W23910A PAUL RD.,Pewaukee,WI,53072,US
Device Description : The NeoCoil Patient Communication and Entertainment (PCE) System is intended to The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
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 3T l6ch Flex SPEEDER Coils are a receive-only phased array coil syst The NeoCoil 3T l6ch Flex SPEEDER Coils are a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest, abdomen, pelvis. head, neck, and spine. The system is compatible with 20, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil 3T l6ch Flex SPEEDER Coils are a receive-only phased array coil syst The NeoCoil 3T l6ch Flex SPEEDER Coils are a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest, abdomen, pelvis. head, neck, and spine. The system is compatible with 20, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : These accessory immobilization devices are intended for use in conjunction with These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SynChron™ Wireless Vector Gating System for CT is a product used to acquire The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SynChron™ Wireless Vector Gating System for CT is a product used to acquire The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SynChron™ Wireless Vector Gating System for CT is a product used to acquire The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil Patient Communication and Entertainment (PCE) System is intended to The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NeoCoil Patient Communication and Entertainment (PCE) System is intended to The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
Device Class : 2
Duns Number: 781155176
Premarket Exempt : No
Prescription Use : Yes