| K-number | K253962 |
| Device name | ClearCheck (RADCC V2.7) |
| Applicant | Radformation, Inc. |
| Product code | IYE |
| Device class | Class II |
| Decision date | Apr 3, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.5050 |
ClearCheck (RADCC V2.7) is software that assists radiation therapy professionals in generating and assessing radiotherapy treatment plan quality. It also helps predict potential collisions between treatment machines and patients or support structures by processing treatment data, imaging data, and structure sets from treatment planning systems.
ClearCheck V2.7 is a Windows-based software application with a graphical user interface that accepts treatment planning system API data and DICOM files. Key differences from the predicate include enhanced image viewer functionality with registration views, improved collision detection algorithm, ability to create custom plan checks, and support for deformed dose evaluation using AutoContour-based deformations.
Not stated in this summary.
ClearCheck V2.7 maintains the same intended use, patient population, and core functionality as the predicate device (ClearCheck RADCC V2, K220583). Both are software-only applications for treatment plan assessment used by trained radiation oncology personnel. Verification and validation testing confirmed that V2.7 outputs match expected results within defined tolerances (0.5% for non-volume constraints, 10% for volume-based constraints), and all regression tests passed.
View the full FDA submission: accessdata.fda.gov