NovaGuide 2 Intelligent Ultrasound
NovaSignal Corporation
NovaSignal Corporation
PMN#
GUDID#
NovaGuide™ 2 Intelligent Ultrasound System - 05-00030
2022-08-19
NovaGuide™ 2 Traditional Ultrasound System - NSC-TCDNG2
2022-08-19
NovaGuide™ Intelligent Ultrasound System - 05-00019
2022-08-19
Lucid Transcranial Doppler Ultrasound System (Lucid TCD) - The Lucid TCD is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity (CBFV) within the major conducting arteries and veins of the head and neck. Additionally, the Lucid TCD measures the occurrence of transient emboli signals within the blood stream.The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
2020-08-31
Lucid Transcranial Doppler System - M1
2017-05-10
2-MHz Transducer, Handheld - The handheld transducer is a 2 MHz single-element ultrasound transducer designed to be held by hand to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase
2017-05-25
2-MHz Headset/Monitoring Transducer - The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase
2017-05-25
Temporal Monitoring Headset - 40-00010
2017-05-25
Remote Control Accessory - The Remote Control Accessory is an optional accessory device designed to replicate the touch screen interface for commonly used commands during exams.
2018-03-20
2Mhz Monitoring Transducer - 8 foot - The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements.The transducer has the following specifications:• 2MHz ± 0.1MHz center frequency• 46mm ± 5mm focal length• 16mm active diameter• Fractional 6dB pulse-echo bandwidth = 60% to 80%• Round-trip insertion loss < 6dB• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase
2018-10-17
Temporal Monitoring Headframe - NA-MOUNT2
2018-10-17
Monitoring Headframe Foam Procedural Set - Procedural set that includes replacement foam for the monitoring headframe.
2018-10-17
NovaKit™ 2 Exam Pack - 25-00004
2022-08-19
NovaKit™ 2 Exam Pack - 25-00004
2022-08-19
NovaBot Automated Headset - NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Lucid TCD, the combined device is referred to as the NovaGuide.The NovaBot is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid TCD (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient's temporal acoustic windows.
2020-08-31
Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack - A box of 10 procedural sets that include replacement foam for the Temporal Monitoring Headframe.
2020-06-05
NeuralBot Procedural Set (Single Use) - The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
2018-07-26
NeuralBot - The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid M1 System (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient’s temporal acoustic windows.
2018-07-09
NovaKit Exam Pack (NovaKit) - The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
2020-08-31
NovaKit Exam Pack (NovaKit) - The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
2020-08-31