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Lucid Transcranial Doppler Ultrasound System (Lucid TCD)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Lucid Transcranial Doppler Ultrasound System (Lucid TCD) FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system probe FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- NA-LUCM1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- NA-LUCM1 FDA UDI
- Primary DI / UDI-DI
- 00850681007221 FDA UDI
- 510(k) Number
- K160442 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Noninvasive vascular ultrasound system probeNoninvasive vascular ultrasound system
Lucid Transcranial Doppler Ultrasound System (Lucid TCD) by Novasignal Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Noninvasive vascular ultrasound system.
- Summit Doppler — CooperSurgical, Inc. · Class II
- Summit Doppler — CooperSurgical, Inc. · Class II
- DigiDop — Newman Medical · Class II
- Vave — VAVE HEALTH INC · Class II
- TRIA II Display Doppler — CooperSurgical, Inc. · Class II
- Summit Doppler — CooperSurgical, Inc. · Class II
- DigiDop — Newman Medical · Class II
- DigiDop — Newman Medical · Class II
Cleared under the same submission
K160442 also covers:
- 2-MHz Transducer, Handheld — Novasignal Corporation
- 2Mhz Monitoring Transducer - 8 foot — Novasignal Corporation
- Remote Control Accessory — Novasignal Corporation
- Temporal Monitoring Headframe — Novasignal Corporation
- Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack — Novasignal Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Novasignal Corporation
Sources (1)
- FDA UDI d57ebc72-7696-4623-975f-5bcabc1ab2ce 35 fields · synced May 31, 2026