Novasignal Corp.

Address:2440 S SEPULVEDA BLVD STE 115,Los Angeles,CA,90064,US

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Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : ITX, IYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : NA – PRB1

Device Description : The handheld transducer is a 2 MHz single-element ultrasound transducer designed 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

Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Device Description : The monitoring transducer is a 2 MHz single-element ultrasound transducer design 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

Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

- Catalog Number : NA – MOUNT1

Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Device Description : The Remote Control Accessory is an optional accessory device designed to replica The Remote Control Accessory is an optional accessory device designed to replicate the touch screen interface for commonly used commands during exams.

Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Device Description : The NeuralBot procedural set contains the following single use items; probe pod The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.

Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : ITX, OQQ, IYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : NA-RBT1

Device Description : The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe 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.

Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : IYN, ITX, OQQ

Prescription Use : Yes

Device Count : 1

Device Description : The monitoring transducer is a 2 MHz single-element ultrasound transducer design 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

Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Device Description : Procedural set that includes replacement foam for the monitoring headframe.

Device Class : 2

Duns Number: 078766464

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1