SurgicalPreview
Basic Information
- Brand Name
- SurgicalPreview
- Primary DI
- B642SURGICALPREVIEW2600
- Version / Model
- 2.6.0
- Catalog Number
- SURGICALPREVIEW260
- Company Name
- ENDOVANTAGE LLC
- Labeler DUNS
- 079324339
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-07
- Public Version
- 2
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- a72464b7-5f03-4d51-80b2-a90e6954356f
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PZO | Software For Visualization Of Vascular Anatomy And Intravascular Devices | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B642SURGICALPREVIEW2500 | HIBCC | ||||
| Primary | B642SURGICALPREVIEW2600 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171534 | 000 |