D2P

Primary DI
00816847021470
Brand
D2P
Company
3D SYSTEMS, INC.
Model
1.0.2
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
Published
2020-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161841000
K183489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161841000D2P3D Systems, Inc.2017-01-09LLZ
K183489000D2P3D Systems, Inc.2019-08-29LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847021470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847021470008168470214708168470214700816847021470

GMDN Terms#

Term, Definition table
TermDefinition
Image segmentation application softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
085049749
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816847021487VSP OrthopedicsPatient Femur Cutting Guide2019-09-11
00816847021494VSP OrthopedicsPatient Femur Marking Guide2019-09-11
00816847021500VSP OrthopedicsPatient Femur Drilling Guide2019-09-11
00816847021517VSP OrthopedicsPatient Femur Template2019-09-11
00816847021524VSP OrthopedicsPatient Tibia Cutting Guide2019-09-11
00816847021531VSP OrthopedicsPatient Tibia Marking Guide2019-09-11
00816847021548VSP OrthopedicsPatient Tibia Drilling Guide2019-09-11
00816847021555VSP OrthopedicsPatient Tibia Template2019-09-11
00816847021562VSP OrthopedicsPatient Pelvic Cutting Guide2019-09-11
00816847021579VSP OrthopedicsPatient Pelvic Marking Guide2019-09-11
00816847021586VSP OrthopedicsPatient Pelvic Drilling Guide2019-09-11
00816847021593VSP OrthopedicsPatient Pelvic Template2019-09-11
00816847021807VSP OrthopedicsAllograft Femur Cutting Guide2019-09-11
00816847021814VSP OrthopedicsAllograft Femur Marking Guide2019-09-11
00816847021821VSP OrthopedicsAllograft Femur Drilling Guide2019-09-11
00816847021838VSP OrthopedicsAllograft Femur Template2019-09-11
00816847021845VSP OrthopedicsAllograft Tibia Cutting Guide2019-09-11
00816847021852VSP OrthopedicsAllograft Tibia Marking Guide2019-09-11
00816847021869VSP OrthopedicsAllograft Tibia Drilling Guide2019-09-11
00816847021876VSP OrthopedicsAllograft Tibia Template2019-09-11

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