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Lucid Transcranial Doppler System

FDA UDI

Class II (US FDA UDI)

by Novasignal Corporation

Identity

Trade Name
Lucid Transcranial Doppler System FDA UDI
Generic Name
Noninvasive vascular ultrasound system probe FDA UDI
Model / Reference
M1 FDA UDI

Identifiers

Catalog Number
NA – LUCM1 FDA UDI
Primary DI / UDI-DI
00850681007009 FDA UDI
510(k) Number
K160442 FDA UDI
FDA Product Code
ITX FDA UDI
IYN FDA UDI
GMDN Term
Noninvasive vascular ultrasound system probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1550 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

Lucid Transcranial Doppler System by Novasignal Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K160442 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novasignal Corporation

Sources (1)

  • FDA UDI 4ad7d5ea-de46-4a4a-b6dd-942055cb6211 35 fields · synced May 30, 2026