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510(k) Data Aggregation
K Number
K240724Device Name
SynthVISION 1.0.0
Manufacturer
Synthesis Health Intelligence Inc
Date Cleared
2024-08-08
(143 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Synthesis Health Intelligence Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SynthVISION is a software application that can be used within a web -browser to process and view DICOM and non-DICOM image data and associated medical in the day-to-day diagnostic activities of medical imaging professionals and those involved in the care of a patient.
Device Description
SynthVISION is a medical imaging viewing software used with off-the-shelf workstation hardware and web browsers for the 2D & 3D diagnostic visualization of DICOM and non-DICOM medical images by intended users such as trained radiologists, technologists and all others involved in the patient's care.
SynthVISION consists of configurable software-only modules that display and process DICOM and non-DICOM images and associated medical information to aid in the day-to-day operations and workflow of imaging healthcare professionals, clinicians and other healthcare practitioners.
SynthVISION has the following primary features and functions -
- Zero-footprint medical image upload, transfer, and display of medical images between facilities
- Easy access to images for all participants in the healthcare process, including radiologists, physicians, nurses and others who participate in patient care
- Serves as information and data management system for DICOM and non-DICOM medical images
- Industry-standard tools for image manipulation, annotation and measurement ●
- Metadata information and orientation labels display
- . Advanced image manipulation functions like view synchronization across series, MIP and MPR
- Advanced image processing filters
- Encrypted transmission of medical images through secured networks
- Encrypted storage of medical images
- . HIPAA-compliant data management, including centralized storage of user activities via audit trails.
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