D2P

GUDID 00816847021470

The D2P software is a stand-alone modular software package that allows easy to use and quick digital 3D model preparation for printing or use by third party applications. The software is aimed at usage by medical staff, technicians, nurses, researchers or lab technicians that wish to create patient specific digital anatomical models for variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printer to create physical models for visual, non-diagnostic use. This modular package includes, but is not limited to the following functions: - DICOM viewer and analysis - Automated segmentation - Editing and pre-printing - Seamless integration with 3D Systems printers - Seamless integration with 3D Systems software packages

3D SYSTEMS, INC.

Image segmentation application software

• Primary Device ID: 00816847021470
• NIH Device Record Key: c174346f-a00c-4721-853a-d53ea3125b2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D2P
• Version Model Number: 1.0.2
• Company DUNS: 085049749
• Company Name: 3D SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816847021470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161841

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-11
• Device Publish Date: 2020-08-03

On-Brand Devices [D2P]

• 00816847022569: The D2P software is a stand-alone modular software package that provides advanced visualization
• 00816847021470: The D2P software is a stand-alone modular software package that allows easy to use and quick dig