AccessGUDID - DEVICE: SurgicalPreview (B642SURGICALPREVIEW3000)

GUDID

Device Identifier (DI) Information

Brand Name: SurgicalPreview
Version or Model: 3.0.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SURGICALPREVIEW300
Company Name: ENDOVANTAGE LLC

Primary DI Number: B642SURGICALPREVIEW3000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079324339 *Terms of Use
Previous DI: B642SURGICALPREVIEW2600

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZO	Software For Visualization Of Vascular Anatomy And Intravascular Devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171534	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fb161874-cdde-4e1e-9898-b7f1461791d0
Public Version Date: December 22, 2021
Public Version Number: 2
DI Record Publish Date: September 12, 2019