Visible Patient Suite

GUDID B373VPS10140

Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals 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 imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images , including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image 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.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.

VISIBLE PATIENT

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• Primary Device ID: B373VPS10140
• NIH Device Record Key: 5b8efaad-bdf3-45f0-a3b9-596c13ad0021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visible Patient Suite
• Version Model Number: 1.0.14
• Company DUNS: 265312689
• Company Name: VISIBLE PATIENT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B373VPS10140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151988

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-23
• Device Publish Date: 2021-07-15

On-Brand Devices [Visible Patient Suite]

• B373VPS1090: Visible Patient Suite is medical imaging software that is intended to provide trained medical pr
• B373VPS10110: Visible Patient Suite is medical imaging software that is intended to provide trained medical p
• B373VPS10100: Visible Patient Suite is medical imaging software that is intended to provide trained medical pr
• B373VPS10150: Visible Patient Suite is medical imaging software that is intended to provide trained medical p
• B373VPS10140: Visible Patient Suite is medical imaging software that is intended to provide trained medical p
• B373VPS10130: Visible Patient Suite is medical imaging software that is intended to provide trained medical p
• B373VPS10170: Visible Patient Suite is medical imaging software that is intended to provide trained medical pr