PROcedure Rehearsal Studio PROcedure Rehearsal Studio

GUDID 00816847021371

Image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning.

3D SYSTEMS, INC.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID00816847021371
NIH Device Record Key77bf4113-8648-4da3-b316-89e0f9af50f7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROcedure Rehearsal Studio
Version Model Number2.0.1.
Catalog NumberPROcedure Rehearsal Studio
Company DUNS085049749
Company Name3D SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com
Phone+97239114444
EmailSimbionix@3DSystems.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816847021371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2016-09-23

Devices Manufactured by 3D SYSTEMS, INC.

00816847022576 - Vantage PSI2023-08-30 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
00816847022606 - Vantage PSI2023-08-30 Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cutting guides.
00816847022583 - Vantage PSI2023-08-15 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
00816847022590 - Vantage PSI2023-08-15 A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the
00816847022613 - VSP Bolus2023-02-15 The 3D Systems VSP Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended t
00816847021470 - D2P2020-08-11 The D2P software is a stand-alone modular software package that allows easy to use and quick digital 3D model preparation for pr
00816847022569 - D2P2020-08-11 The D2P software is a stand-alone modular software package that provides advanced visualization of DICOM imaging data. This modu
00816847022446 - VSP Orthopedics2019-11-27 A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference

Trademark Results [PROcedure Rehearsal Studio]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROCEDURE REHEARSAL STUDIO
PROCEDURE REHEARSAL STUDIO
77566372 3797749 Live/Registered
3D SYSTEMS, INC.
2008-09-10
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