Duns Number:617041967
Device Description: The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radi The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
Catalog Number
-
Brand Name
.decimal Astroid Dosimetry App
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150547
Product Code
MUJ
Product Code Name
System,Planning,Radiation Therapy Treatment
Public Device Record Key
698c2fb0-c562-4c86-b8d2-21cc81608163
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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. | 9 |