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510(k) Data Aggregation
K Number
K153289Device Name
HEALTHMYNE
Manufacturer
Date Cleared
2016-01-15
(63 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEALTHMYNE, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HealthMyne software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the HL7 and DICOM (including DICOM-RT) standards, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements, and export the product automatically and semiautomatically segments normal structures and abnormal structures (for example, nodules and lesions), and provides metrics for the structures.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information (for example, image analysis) that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
Device Description
HealthMyne accesses the information in real-time so that current patients and images are available to a clinician. The clinician can filter and search the patient and image metadata to find the desired patient(s) and/or image(s). The clinician can view the images in various hanging protocol layouts. The layouts contain viewports of the slices within the image set, each annotated with patient information. Within the viewports the clinician can manipulate the image using standard tools: scroll, pan, zoom, window and level, and view the location of the slice in other viewports. The system can automatically segment and register data sets, and calculate metrics on clinician-identified nodules. When a clinician identifies a seed point for a nodule, the system automatically finds the extent of the nodule. Regions of interest (organs and nodules) can be viewed on the 2D data sets as contours and as 3D models. Metrics can be used to aid in analysis of a study, including the American College of Radiology RADS standards, and specifically with this release the LungRADs categories.
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K Number
K152186Device Name
HealthMyne PACS
Manufacturer
Date Cleared
2015-08-20
(15 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEALTHMYNE, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HealthMyne PACS software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne PACS software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM (including DICOM-RT) standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
Device Description
HealthMyne PACS accesses the information in real-time so that current patients and images are available to a clinician. The clinician can filter and search the patient and image metadata to find the desired patient(s) and/or image(s). The clinician can view the images in various hanging protocol layouts. The layouts contain viewports of the slices within the image set, each annotated with patient information. Within the viewports the clinician can manipulate the image using standard tools: scroll, pan, zoom, window and level, and view the location of the slice in other viewports.
Ask a Question
Ask a specific question about this device
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