SurgicalPreview SURGICALPREVIEW300

GUDID B642SURGICALPREVIEW2600

SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview® provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview® enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview® also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview® can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider’s judgement and analysis of the patient’s condition.

ENDOVANTAGE LLC

Vascular modelling web-based application software
Primary Device IDB642SURGICALPREVIEW2600
NIH Device Record Keyfb161874-cdde-4e1e-9898-b7f1461791d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgicalPreview
Version Model Number3.0.0
Catalog NumberSURGICALPREVIEW300
Company DUNS079324339
Company NameENDOVANTAGE LLC
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB642SURGICALPREVIEW2600 [Previous]
HIBCCB642SURGICALPREVIEW3000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZOSoftware For Visualization Of Vascular Anatomy And Intravascular Devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-20
Device Publish Date2019-09-12

On-Brand Devices [SurgicalPreview]

B642SURGICALPREVIEW2300SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
B642SURGICALPREVIEW2200SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
B642SURGICALPREVIEW2100Device Description (max 2000 characters): SurgicalPreview is a stand-alone software application
B642SURGICALPREVIEW1200SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
B642SURGICALPREVIEW1100SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
B642SURGICALPREVIEW100SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
B642SURGICALPREVIEW2400SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
B642SURGICALPREVIEW2500SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
B642SURGICALPREVIEW2600SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
B642SURGICALPREVIEW3000SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
B642SURGICALPREVIEW3100SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
B642SURGICALPREVIEW3200SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac

Trademark Results [SurgicalPreview]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURGICALPREVIEW
SURGICALPREVIEW
87324106 5342953 Live/Registered
EndoVantage, LLC
2017-02-03

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