Duns Number:122782324
Device Description: Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
Catalog Number
-
Brand Name
Sonocubic 3D Ultrasound Software
Version/Model Number
Classic
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 03, 2016
Issuing Agency
In HIBCC
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
K003672
Product Code
IYO
Product Code Name
System, Imaging, Pulsed Echo, Ultrasonic
Public Device Record Key
1ec57650-9772-424e-b0f7-da8b9c5ee28e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 03, 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. | 2 |