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510(k) Data Aggregation
K Number
K212896Device Name
Visible Patient Suite
Manufacturer
Visible Patient, SAS
Date Cleared
2021-11-05
(56 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Visible Patient, SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning for both pediatric and adult patients. 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 Ul to segment anatomical structures, which are visible in the image data (bones, organs, vascular/ainway 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.
Device Description
Visible Patient Suite is a software suite and includes three software components: Visible Patient Sender (VP Sender), Visible Patient Lab (VP Lab), and Visible Patient Planning (VP Planning). Visible Patient Lab is the main software component of Visible Patient Suite and includes all modules available in the software suite (except for the DICOM files anonymization module present in the Visible Patient Sender module).
a) Visible Patient Sender
Visible Patient Sender includes only modules dedicated to data management. The software is a simple tool to anonymize multidimensional digital images acquired from a variety of medical imaqinq modalities (DICOM images). There is no 3D data volume interpretation in this software.
b) Visible Patient Lab
Visible Patient Lab includes all Visible Patient Suite modules: data management (except for DICOM files anonymization module), data analysis and data processing. This software offers a flexible solution to help trained medical professionals with image processing knowledge (usually radiologists or radiologist technicians) in (1) the evaluation of patient's anatomy and pathology, and (2) in the creation of a 3D model of the patient's anatomy. This software proposes flexible workflow options: visualization of patient's anatomy and pathology from medical images; creation a 3D model of the patient's anatomical structures, organ segments and volumetric data; creation of an anatomical atlas (a colored image where each color represents a structure); and exports these medical data to be analyzed or reviewed later.
c) Visible Patient Planning
Visible Patient Planning includes modules dedicated to data management and data analysis, and simply contains a subset of the software modules present in Visible Patient Lab. This software offers a flexible visualization solution to help trained medical professionals (clinicians) in the evaluation of patient's anatomy and pathology to plan therapy or surgery.
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K Number
K151988Device Name
Visible Patient Suite
Manufacturer
VISIBLE PATIENT, SAS
Date Cleared
2015-10-15
(90 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VISIBLE PATIENT, SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The Visible Patient Suite is a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians. A physician, provided with ample opportunity for competent human intervention, interprets images and information being displayed.
In sum, Visible Patient Suite is a software suite and includes three software components: Visible Patient Sender (VP Sender), Visible Patient Lab (VP Lab), and Visible Patient Planning (VP Planning). Visible Patient Lab is the main software component of Visible Patient Suite and includes all modules available in the software suite (except for the DICOM files anonymization module present in the Visible Patient Sender module).
Visible Patient Sender includes only modules dedicated to data management. The software is a simple tool to anonymize multidimensional digital images acquired from a variety of medical imaging modalities (DICOM images). There is no 3D data volume interpretation in this software.
Visible Patient Lab includes all Visible Patient Suite modules: data management (except for DICOM files anonymization module), data analysis and data processing. This software offers a flexible solution to help trained medical professionals with image processing knowledge (usually radiologists or radiologist technicians) in (1) the evaluation of patient's anatomy and pathology, and (2) in the creation of a 3D model of the patient's anatomy. This software proposes flexible workflow options: visualization of patient's anatomy and pathology from medical images; creation a 3D model of the patient's anatomical structures, organ segments and volumetric data; creation of an anatomical atlas (a colored image where each color represents a structure); and exports these medical data to be analyzed or reviewed later.
Visible Patient Planning includes modules dedicated to data management and data analysis, and simply contains a subset of the software modules present in Visible Patient Lab. This software offers a flexible visualization solution to help trained medical professionals (clinicians) in the evaluation of patient's anatomy and pathology to plan therapy or surgery.
Ask a Question
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