2-MHz Headset/Monitoring Transducer NA - PRB2

GUDID 00850681007023

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

NEURAL ANALYTICS, INC.

Noninvasive vascular ultrasound system probe

• Primary Device ID: 00850681007023
• NIH Device Record Key: 6939f523-1347-4c18-99c6-d50cbc47a8ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2-MHz Headset/Monitoring Transducer
• Version Model Number: 40-00009
• Catalog Number: NA - PRB2
• Company DUNS: 078766464
• Company Name: NEURAL ANALYTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850681007023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160442

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-25

Devices Manufactured by NEURAL ANALYTICS, INC.

• 00850681007153 - 2Mhz Monitoring Transducer - 8 foot: 2018-11-19 The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity
• 00850681007160 - Temporal Monitoring Headframe: 2018-11-19
• 00850681007177 - Monitoring Headframe Foam Procedural Set: 2018-11-19 Procedural set that includes replacement foam for the Neural Analytics monitoring headframe.
• 00850681007115 - NeuralBot Procedural Set (Single Use): 2018-08-27 The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabil
• 00850681007122 - NeuralBot: 2018-08-09 The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleare
• 00850681007009 - Lucid Transcranial Doppler System: 2018-07-06 The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuri
• 00850681007016 - 2-MHz Transducer, Handheld: 2018-07-06 The handheld transducer is a 2 MHz single-element ultrasound transducer designed to be held by hand to perform velocity measurem
• 00850681007023 - 2-MHz Headset/Monitoring Transducer: 2018-07-06The 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
• 00850681007023 - 2-MHz Headset/Monitoring Transducer: 2018-07-06 The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity