Duns Number:071829634
Device Description: SOFTWARWE- DICOM EXTENSION OPTION - Provides capability for storing NIVP3 patient data in SOFTWARWE- DICOM EXTENSION OPTION - Provides capability for storing NIVP3 patient data in a DICOM system.
Catalog Number
05072
Brand Name
Hokanson
Version/Model Number
5.40
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
K970570
Product Code
DQK
Product Code Name
Computer, Diagnostic, Programmable
Public Device Record Key
932ece79-f9fc-4ea1-ac98-4b6ba42be204
Public Version Date
October 02, 2020
Public Version Number
5
DI Record Publish Date
September 16, 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. | 218 |