Duns Number:080444608
Device Description: ClearCalc is a software intended to assist radiation treatment planners in determining if ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
Catalog Number
-
Brand Name
ClearCalc
Version/Model Number
2.0
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193640
Product Code
MUJ
Product Code Name
System, Planning, Radiation Therapy Treatment
Public Device Record Key
af01931c-eee0-4223-aff0-06ecb1440921
Public Version Date
October 19, 2021
Public Version Number
1
DI Record Publish Date
October 11, 2021
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. | 5 |