SurgicalPreview

Primary DI
B642SURGICALPREVIEW2200
Brand
SurgicalPreview
Company
ENDOVANTAGE LLC
Model
2.2.0
Catalog number
SURGICALPREVIEW220
Device description
Device Description (max 2000 characters):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 assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 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. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
Published
2018-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PZOSoftware For Visualization Of Vascular Anatomy And Intravascular Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZOSoftware For Visualization Of Vascular Anatomy And Intravascular DevicesRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171534000SurgicalPreviewEndo Vantage, LLC2017-11-08PZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B642SURGICALPREVIEW2100PreviousHIBCC0
B642SURGICALPREVIEW2200PreviousHIBCC0
B642SURGICALPREVIEW2300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular modelling web-based application softwareAn application software program intended to aid assessment of vascular stenosis and/or endovascular interventions, by producing a three-dimensional (3-D) cardiovascular model which has features of predicted blood flow data and/or endovascular device deployments. It typically uses computed tomography (CT) images and may be intended as an alternative to invasive techniques (i.e., invasive blood pressure, invasive fractional flow reserve, angiography); it is not intended to store patient records.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079324339
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B642SURGICALPREVIEW3300SurgicalPreview3.3.0SURGICALPREVEW3302019-11-27
B642SURGICALPREVIEW3200SurgicalPreview3.2.0SURGICALPREVIEW3202019-11-05
B642SURGICALPREVIEW3100SurgicalPreview3.1.0SURGICALPREVIEW3102019-10-23
B642SURGICALPREVIEW3000SurgicalPreview3.0.0SURGICALPREVIEW3002019-09-12
B642SURGICALPREVIEW2600SurgicalPreview2.6.0SURGICALPREVIEW2602019-06-07
B642SURGICALPREVIEW2500SurgicalPreview2.5.0SURGICALPREVIEW2502019-04-30
B642SURGICALPREVIEW2400SurgicalPreview2.4.0SURGICALPREVIEW2402019-02-07
B642SURGICALPREVIEW100SurgicalPreview1.0SURGICALPREVIEW102018-04-06
B642SURGICALPREVIEW1100SurgicalPreview1.1.0SURGICALPREVIEW1102018-04-16
B642SURGICALPREVIEW1200SurgicalPreview1.2.0SURGICALPREVIEW1202018-04-29
B642SURGICALPREVIEW2100SurgicalPreview2.1.0SURGICALPREVIEW2102018-11-30
B642SURGICALPREVIEW2300SurgicalPreview2.3.0SURGICALPREVIEW2302019-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665786000018Sim&SizeSIM&CUREPZO2026-03-13
08437025622016ANKYRASMENTICE SPAIN S.L.PZO2026-02-26
03665786000070Sim&SizeSIM&CUREPZO2025-02-11
03665786000032Sim&SizeSIM&CUREPZO2023-03-14
03665786000063Sim&SizeSIM&CUREPZO2022-06-24
03665786000049Sim&SizeSIM&CUREPZO2021-06-06
03665786000056Sim&SizeSIM&CUREPZO2021-06-06
03665786000025Sim&SizeSIM&CUREPZO2020-07-30
B642SURGICALPREVIEW3300SurgicalPreviewENDOVANTAGE LLCPZO2019-11-27
B642SURGICALPREVIEW3200SurgicalPreviewENDOVANTAGE LLCPZO2019-11-05
B642SURGICALPREVIEW3100SurgicalPreviewENDOVANTAGE LLCPZO2019-10-23
B642SURGICALPREVIEW3000SurgicalPreviewENDOVANTAGE LLCPZO2019-09-12
B642SURGICALPREVIEW2600SurgicalPreviewENDOVANTAGE LLCPZO2019-06-07
B642SURGICALPREVIEW2500SurgicalPreviewENDOVANTAGE LLCPZO2019-04-30
B642SURGICALPREVIEW2400SurgicalPreviewENDOVANTAGE LLCPZO2019-02-07
B642SURGICALPREVIEW2300SurgicalPreviewENDOVANTAGE LLCPZO2019-01-28
B642SURGICALPREVIEW2100SurgicalPreviewENDOVANTAGE LLCPZO2018-11-30
B642SURGICALPREVIEW1200SurgicalPreviewENDOVANTAGE LLCPZO2018-04-29
B642SURGICALPREVIEW1100SurgicalPreviewENDOVANTAGE LLCPZO2018-04-16
B642SURGICALPREVIEW100SurgicalPreviewENDOVANTAGE LLCPZO2018-04-06