Duns Number:788084705
Device Description: Standard Imaging LinacView Software is a stand alone software medical device used for logf Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems.
Catalog Number
91330
Brand Name
Standard Imaging LinacView Software
Version/Model Number
91330
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
-
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
21f8d3dd-95bd-4b9d-8ed3-e691c9a29a24
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 20, 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. | 7 |