MapRT

MapRT is a software-based collision avoidance and dose optimization tool used by radiotherapy professionals during CT simulation and treatment planning. It creates a 3D model of patients and treatment accessories using two lateral wide-field cameras, then calculates clearance maps for every combination of couch and gantry angles to predict and prevent collisions between the treatment machine and patient or support structures.

MapRT v1.2 is functionally equivalent to the predicate device (MapRT v1.0) with minor visual-only changes to the graphical user interface that do not impact clinical workflow. Both versions use Windows operating systems, accept treatment planning system data, employ local hardware with adhesive couch markers, perform collision simulation with ±2cm accuracy, and generate interactive clearance maps showing collision-free and collision-prone angle combinations.

The document cites ISO 62366-1:2015/A1:2020 (medical device user interface validation) and references FDA guidance on 510(k) submissions and device changes. Verification and validation testing employed pass/fail criteria with summative evaluation techniques per the stated standards.

MapRT v1.2 maintains identical indications for use, intended users, functionality, input/output methods, and simulation accuracy as the cleared predicate device K231185. The only change is a minor redesign of the graphical user interface elements, which Vision RT argues does not affect safety or effectiveness because the underlying software logic, collision detection algorithms, and clinical workflow remain unchanged. Verification and validation testing confirmed the device continues to meet design specifications and perform as intended.