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510(k) Data Aggregation
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Applicant Name (Manufacturer) :
Hutom Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RUS is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients. RUS accepts DICOM compliant medical images acquired from iodine contrast-enhanced abdomen CT.
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, image fusion, surface rendering, measurements, reporting, storing, 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 structures, etc.), including interactive segmentation tools, basic image filters, etc.
It also includes detection and labeling tools of organ segments, including path definition through vascular 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
RUS uses DICOM (Digital Imaging and Communications in Medicine) standards to analyze CT images. This software provides trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. By observing the medical images standard protocol (DICOM standards), this software can receive transmitted images from medical imaging devices through the h-Server and can be interfaced with PACS (Picture Archiving and Communication System).
RUS allows surgical planning by 3D modeling from patient's CT data. Surgical planning in RUS does not replace actual surgery and can only be used as an auxiliary tool.
CT is taken at the hospital, the patient's CT data is obtained from PACS, and the CT data is transferred from PACS to h-Server. When CT data and patient information are registered in the h-Server, the data is pseudonymized and anonymized and safely moved to the h-Space. If you request hu3D production by registering CT data and patient information through h-Server, hu3D will be provided within 72 hours. Then you may download the hu3D model through RUS Stomach Planning and perform Surgical planning.
RUS is a software suite and includes three software components: h-Server, h-Space, and RUS Stomach Planning.
1) h-Server
h-Server includes modules dedicated to data management and data gateway. The software is a simple tool either to anonymize or pseudonymize multidimensional digital images acquired from a variety of medical imaging modalities (DICOM images). There is no 3D data volume interpretation in this software.
2) h-Space
h-Space includes data management (except for DICOM files anonymization/pseudonymization module) and 3D reconstruction. 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 (2) in the creation of a 3D model of the patient's anatomy. This software proposes flexible workflow options: visualization of patient's anatomy 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.
3) RUS Stomach Planning
RUS Stomach Planning includes modules dedicated to patient & data management and surgical planning. This software offers a flexible visualization solution to help trained medical professionals (clinicians) in the evaluation of patient's anatomy to plan therapy or surgery.
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