Duns Number:788084705
Device Description: Standard Imaging IMSure QA Software is a stand alone software medical device used for moni Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems.
Catalog Number
91326
Brand Name
Standard Imaging IMSure QA Software
Version/Model Number
v3
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
K031975
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
4499701b-5225-4a11-af15-0f910a4e7b36
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 |