3DXR

3DXR is a post-processing software application that runs on the Advantage Workstation platform and performs three-dimensional reconstruction of cone-beam CT (CBCT) images acquired from interventional X-ray systems. The reconstructed 3D volumes are used by physicians for diagnosis, surgical planning, interventional procedures, and treatment follow-up of vessels, bones, soft tissues, and other internal body structures.

The proposed 3DXR includes a new CleaRecon DL option powered by deep-learning convolutional neural networks to remove streak artifacts caused by pulsatile blood flow, an enhanced 3DStent feature that compensates for both respiratory and cardiac motion (vs. respiratory only in the predicate), and improved Imaging Purposes functionality. All other features—Motion Freeze, Metal Artifact Reduction, Active Tracker Detection, Iodine Streaks Reduction, Scatter Reduction, Extended Range, and CT Format—remain identical to the predicate device.

NEMA PS 3.1–3.20 Digital Imaging and Communications in Medicine (DICOM) standard; 21 CFR 820 Quality System Regulations; ISO 13485.

The device maintains identical indications for use and intended use as the predicate. Design control testing identified no new hazards or unexpected results. The CleaRecon DL deep-learning algorithm was validated through engineering bench testing (showing statistically significant reduction in Mean Absolute Error and increase in Structural Similarity Index on test datasets independent of training data) and retrospective clinical evaluation across 110 patient exams from 13 sites, where 98% of physicians rated CleaRecon DL-reconstructed images as clearer than conventional reconstructions with no artificially created or hidden anatomical structures. The adult-only population limitation for CleaRecon DL is a narrowing of use, not a new safety concern.