SurgicalPreview SURGICALPREVEW330

GUDID B642SURGICALPREVIEW3200

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 ID: B642SURGICALPREVIEW3200
• NIH Device Record Key: 7e379e1e-502d-48bf-801f-2450a74b08a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgicalPreview
• Version Model Number: 3.3.0
• Catalog Number: SURGICALPREVEW330
• Company DUNS: 079324339
• Company Name: ENDOVANTAGE LLC
• 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
HIBCC	B642SURGICALPREVIEW3200 [Previous]
HIBCC	B642SURGICALPREVIEW3300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171534

FDA Product Code

• PZO: Software For Visualization Of Vascular Anatomy And Intravascular Devices

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: 2019-12-05
• Device Publish Date: 2019-11-27

On-Brand Devices [SurgicalPreview]

• B642SURGICALPREVIEW2300: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW2200: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW2100: Device Description (max 2000 characters): SurgicalPreview is a stand-alone software application
• B642SURGICALPREVIEW1200: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW1100: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW100: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW2400: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW2500: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW2600: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW3000: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW3100: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW3200: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac