D2P is a software tool developed by 3D Systems that processes medical imaging data (DICOM) to create 3D segmentations and physical models. It assists clinicians in surgical planning by allowing the generation of accurate physical replicas of anatomical regions from imaging data, supporting diagnosis and treatment decisions in cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal areas.
Intended Use
The D2P software is intended for use as a software interface and image segmentation system for transferring DICOM imaging information and pre-operative surgical planning, producing output files for physical replicas used adjunctively with other diagnostic tools for various anatomical applications.
Technology
D2P software provides advanced visualization, automated segmentation using a deep learning neural network, editing, and seamless integration with 3D printers and virtual reality visualization. It supports removal of images from DICOM data sets and printing of physical anatomic models for diagnostic use.
Performance
Validation included measurement accuracy, usability, and decimation studies which confirmed performance within specifications. Printing of physical anatomic models for multiple applications was demonstrated to be accurate, showing substantial equivalence to predicate device without raising new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/17/2018
8 months - 2
FDA Approval
8/29/2019
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