Duns Number:413819707
Device Description: Software medical device. Assists the interventionalist and surgeon with image guidance dur Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.
Catalog Number
001011
Brand Name
EchoNavigator
Version/Model Number
EchoNavigator - 3
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
K121781,K200713
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
d7adee38-a39c-48b2-9468-490f9e7d0e56
Public Version Date
November 13, 2020
Public Version Number
10
DI Record Publish Date
September 13, 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. | 349 |