D2P
Basic Information
- Brand Name
- D2P
- Primary DI
- 00816847021470
- Version / Model
- 1.0.2
- Company Name
- 3D SYSTEMS, INC.
- Labeler DUNS
- 085049749
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-03
- Public Version
- 3
- Public Version Date
- 2023-08-30
- Public Version Status
- Update
- Public Device Record Key
- c174346f-a00c-4721-853a-d53ea3125b2e
Device Description
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47502 | Image segmentation application software | An application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816847021470 | GS1 |