Duns Number:081092366
Device Description: ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiat ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support.
Catalog Number
-
Brand Name
ProKnow DS
Version/Model Number
1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182855
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
7a6e089c-61f8-4871-a959-d83026ff7788
Public Version Date
May 23, 2019
Public Version Number
2
DI Record Publish Date
April 01, 2019
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. | 1 |