D2P

GUDID 00816847022569

The D2P software is a stand-alone modular software package that provides advanced visualization of DICOM imaging data. 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 - Seamless integration with Virtual Reality visualization for non-diagnostic use

3D SYSTEMS, INC.

Image segmentation application software

• Primary Device ID: 00816847022569
• NIH Device Record Key: 9bd4a89d-7f00-4e93-9865-e23a13127fff
• 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	00816847022569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161841
• Premarket Notification: K183489

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