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FDA-cleared K183489

D2P

3D Systems, Inc.

Authorized purpose: D2P is a software interface and image-segmentation system for transferring DICOM imaging information from a medical scanner to an output file and is also preoperative software for surgical planning. The output may be used to produce a physical replica for adjunctive use with other diagnostic tools and expert clinical judgment in cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal applications.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal anatomy
Decision
2019-08-29