Duns Number:600054688
Device Description: The Digi-Lite System is indicated for non-invasive evaluation of intracranial and extracra The Digi-Lite System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use. The product includes a Pentium M or equivalent processor, minimum 60 Gbyte hard disc, USB, RS232, LAN 10/100 RJ-45 network connection, a PC keyboard, mouse, touch screen of 15″ TFT color SVGA that provides 1024 × 768 points graphic resolution.
Catalog Number
-
Brand Name
Digi-Lite
Version/Model Number
Digi-Lite
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
K062578
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
fd84715f-9aa4-4574-890a-4222c944e0a0
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
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. | 7 |