Duns Number:265312689
Device Description: Visible Patient Suite is medical imaging software that is intended to provide trained medi Visible Patient Suite is medical imaging software that is intended to provide trained medicalprofessionals with tools to aid them in reading, interpreting, reporting, and treatment planning.Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imagingdevices, including CT, MR.This product is not intended for use with or for the primary diagnostic interpretation ofMammography images.The software provides several categories of tools. It includes basic imaging tools for generalimages, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-PlanarReconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, generalimage management and administration tools, etc.It includes a basic image processing workflow and a custom UI to segment anatomical structures,which are visible in the image data (bones, organs, vascular/airway structures, etc.), includinginteractive segmentation tools, basic image filters, etc.It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), includingpath definition through vascular/airway, approximation of vascular/airway territories from tubularstructures and interactive labeling.The software is designed to be used by trained professionals (including physicians, surgeons andtechnicians) and is intended to assist the clinician who is solely responsible for making all finalpatient management decisions.
Catalog Number
-
Brand Name
Visible Patient Suite
Version/Model Number
1.0.10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151988
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
04a51234-7c58-458b-96ae-70993926c5d4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |