Lucid Transcranial Doppler Ultrasound System (Lucid TCD) NA-LUCM1

GUDID 00850681007221

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.

Novasignal Corp.

Noninvasive vascular ultrasound system probe

• Primary Device ID: 00850681007221
• NIH Device Record Key: d57ebc72-7696-4623-975f-5bcabc1ab2ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucid Transcranial Doppler Ultrasound System (Lucid TCD)
• Version Model Number: NA-LUCM1
• Catalog Number: NA-LUCM1
• Company DUNS: 078766464
• Company Name: Novasignal Corp.
• 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	00850681007221 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-08
• Device Publish Date: 2020-08-31

Devices Manufactured by Novasignal Corp.

• 00850681007351 - NovaKit™ 2 Exam Pack: 2022-08-29
• 00850681007399 - NovaGuide™ 2 Intelligent Ultrasound System: 2022-08-29
• 00850681007405 - NovaGuide™ 2 Traditional Ultrasound System: 2022-08-29
• 00850681007443 - NovaGuide™ Intelligent Ultrasound System: 2022-08-29
• 00850681007184 - NovaBot Automated Headset: 2020-09-08 NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Lucid TCD, the combined device is referred to as th
• 10850681007198 - NovaKit Exam Pack (NovaKit): 2020-09-08 The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padd
• 00850681007221 - Lucid Transcranial Doppler Ultrasound System (Lucid TCD): 2020-09-08The 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.
• 00850681007221 - Lucid Transcranial Doppler Ultrasound System (Lucid TCD): 2020-09-08 The Lucid TCD is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and
• 10850681007174 - Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack: 2020-08-03 A box of 10 procedural sets that include replacement foam for the Neural Analytics Temporal Monitoring Headframe.