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510(k) Data Aggregation
K Number
K152186Device Name
HealthMyne PACS
Manufacturer
HEALTHMYNE, INC.
Date Cleared
2015-08-20
(15 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEALTHMYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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