AlignRT Plus (8.0)

AlignRT Plus is a video-based three-dimensional surface imaging system that monitors patient positioning before and during radiotherapy treatment. It tracks respiratory motion for 4D CT reconstruction, verifies patient identity, positions and monitors patients during radiation delivery, automatically withholds or gates the beam based on respiratory motion, performs quality assurance on imaging equipment, visualizes Cherenkov radiation signals, and communicates with other radiotherapy systems.

The subject device (v8.1) maintains the same video-based 3D surface imaging and surface matching software principles as the predicate device (v7.3). Two new features are added: Beam Guide provides on-screen visualization of intended radiation fields to support patient setup without controlling radiation delivery, and Auto ROI automatically generates region-of-interest templates for standard treatment sites while allowing clinician review and modification. System performance specifications remain identical, including positioning accuracy of <1mm and respiratory tracking accuracy of ≤0.5mm.

IEC 60601-1 Edition 3.2 (electrical safety), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), IEC 62366-1:2015/A1:2020 (usability), ANSI/AAMI/IEC 62304:2006/A1:2016 (software verification), ISO 13485 (quality management), and ISO 14971 (risk management).

No changes were made to the indications for use or intended use of the device. The two new features (Beam Guide and Auto ROI) do not alter the core technological principles or raise new safety or effectiveness questions. Comprehensive verification and validation testing confirms identical performance specifications to the predicate device. Updated testing standards (electrical safety, EMC) represent methodology improvements consistent with current FDA guidance and do not affect device safety or performance.