Lucid Transcranial Doppler System NA – LUCM1

GUDID 00850681007009

The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. Additionally, the Lucid M1 System 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.

NEURAL ANALYTICS, INC.

Noninvasive vascular ultrasound system probe

• Primary Device ID: 00850681007009
• NIH Device Record Key: 4ad7d5ea-de46-4a4a-b6dd-942055cb6211
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucid Transcranial Doppler System
• Version Model Number: M1
• Catalog Number: NA – LUCM1
• 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	00850681007009 [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: 2017-05-10

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: 2018-07-06The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. Additionally, the Lucid M1 System 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.
• 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