NeuralBot NA-RBT1

GUDID 00850681007122

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.

NEURAL ANALYTICS, INC.

Noninvasive vascular ultrasound system, line-powered

• Primary Device ID: 00850681007122
• NIH Device Record Key: 540345b1-9001-4d30-819a-fc60c4941bbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuralBot
• Version Model Number: 1.x
• Catalog Number: NA-RBT1
• 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	00850681007122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180455

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-09
• Device Publish Date: 2018-07-09

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: 2018-08-09The 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.
• 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: 2018-07-06 The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity