Duns Number:462279436
Device Description: Radiance V3 is a software system intended for treatment planning and analysis of radiation Radiance V3 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.The system functionality can be configured based on user needs.The intended users of Radiance V3 shall be clinically qualified radiation therapy staff trained in using the system.
Catalog Number
-
Brand Name
radiance
Version/Model Number
3
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
K153368
Product Code
MUJ
Product Code Name
System,Planning,Radiation Therapy Treatment
Public Device Record Key
2a7ca56f-643f-4b3e-8597-2a8c928f8968
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 23, 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. | 2 |