DEVICE: SurgicalPreview (B642SURGICALPREVIEW2400)
Device Identifier (DI) Information
SurgicalPreview
2.4.0
In Commercial Distribution
SURGICALPREVIEW240
ENDOVANTAGE LLC
2.4.0
In Commercial Distribution
SURGICALPREVIEW240
ENDOVANTAGE LLC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61213 | Vascular modelling software |
A stand-alone software application 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. It is designed to be installed on an off-the-shelf computer/smart device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PZO | Software For Visualization Of Vascular Anatomy And Intravascular Devices |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K171534 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
97b0e291-e164-4504-9fb5-c5cafcdc065d
December 22, 2021
2
February 07, 2019
December 22, 2021
2
February 07, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined