Identity
- Trade Name
- NeuralBot FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1.x FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- NA-RBT1 FDA UDI
- Primary DI / UDI-DI
- 00850681007122 FDA UDI
- 510(k) Number
- K180455 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIOQQ FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 FDA UDI
- Commercial Distribution
- Not 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
NeuralBot by Novasignal Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novasignal Corporation
Sources (1)
- FDA UDI 540345b1-9001-4d30-819a-fc60c4941bbf 36 fields · synced Jun 8, 2026