Duns Number:788084705
Device Description: Standard Imaging PIPSpro Software is a stand alone software medical device used for QA che Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.
Catalog Number
91309
Brand Name
Standard Imaging PIPSpro Software
Version/Model Number
v5
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
K042733
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
186d9f3b-ac9e-4f27-a9e2-131c5d4c8a32
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 11, 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. | 7 |