Duns Number:078766464
Device Description: The Lucid TCD is a medical ultrasound system intended for use as an adjunct to the standar 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.
Catalog Number
NA-LUCM1
Brand Name
Lucid Transcranial Doppler Ultrasound System (Lucid TCD)
Version/Model Number
NA-LUCM1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160442
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
d57ebc72-7696-4623-975f-5bcabc1ab2ce
Public Version Date
August 19, 2022
Public Version Number
2
DI Record Publish Date
August 31, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |