Duns Number:203044268
Device Description: The ExactVu high resolution micro-ultrasound system is intended for use by qualified medic The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
Catalog Number
EV-SYS-120
Brand Name
ExactVu High Resolution Micro-Ultrasound System
Version/Model Number
1.0
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162972
Product Code
IYO
Product Code Name
System, Imaging, Pulsed Echo, Ultrasonic
Public Device Record Key
ecea8a4c-944a-4b2b-9d9b-c4846b537e24
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
February 08, 2017
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 |