| K-number | K252863 |
| Device name | ClearCalc Model RADCA V2.6 |
| Applicant | Radformation, Inc. |
| Product code | MUJ |
| Device class | Class II |
| Decision date | Dec 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.5050 |
ClearCalc Model RADCA V2.6 is software that assists radiation treatment planners in verifying the accuracy of their treatment planning calculations. It uses treatment data, image data, and structure sets from supported treatment planning systems to perform independent dose and monitor unit (MU) calculations, helping clinicians ensure their planned treatments are accurate.
The device runs on Windows operating systems and performs dose/MU calculations using either a local calculation engine or Monte Carlo algorithm. V2.6 adds support for RayStation and Monaco treatment planning systems via API integration, expanded machine output file formats including electronic portal imaging device (EPID) pixel intensity maps, and per-field individual outputs for proton calculations. The graphical user interface and reporting capabilities remain substantially equivalent to the predicate device.
Not stated in this summary.
ClearCalc V2.6 is substantially equivalent to its predicate device (ClearCalc Model RADCA V2, K220582) because the indications for use, patient population, intended users, and core algorithms remain unchanged. The new features—TPS support, EPID file format handling, and enhanced proton reporting—utilize existing computational frameworks already validated in the predicate. Verification and validation testing confirmed the software functions as intended with passing regression tests, and no new safety or effectiveness concerns are raised by the technological differences.
View the full FDA submission: accessdata.fda.gov