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510(k) Data Aggregation
K Number
K222476Device Name
OmegaAI Image Viewer
Manufacturer
Date Cleared
2022-11-17
(93 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RamSoft Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OmegaAI Image Viewer is software for diagnostic and clinical review intended for use in General Radiology (images from modalities including CR, CT, DX, MR, MG, NM, US, PET, RG, SC, VL, XA, Film Digitizer), Interventional Radiology, cardiology, oncology, obstetrics and gynecology, ENT, orthopedics, internal medicine, emergency medicine, dermatology, dentistry, cardiology, Pathology (i.e., to review captured images/videos from a sample) and other healthcare imaging applications.
OmegaAI Image Viewer is intended to be used with off the shelf computing devices. Display monitors used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, regulatory approvals and with quality control requirements for their use and maintenance. With appropriate display monitors, lighting, image quality, and level of lossy image compression, the OmegaAI Image Viewer is intended for dagnostic purposes (on desktorms) and as a non-diagnostic review tool (on mobile platforms) to be used by trained healthcare professionals. Display calibration and lighting conditions should be verified by viewing a test pattern prior to use for diagnostic purposes.
OmegaAI Image Viewer supports major desktop and mobile browsers such as Microsoft Edge, Chrome, Safari, Apple iOS, Android, Windows. OmegaAI Image Viewer displays both lossy compressed images. Each healtheare professional must ensure that they have the necessary environment to ensure the appropriate image quality for their clinical purpose and determine the level of lossy image compression for their purpose. Lossy image compression should not be used for primary reading in mammography.
OmegaAI Image Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. OmegaAI Image Viewer can be used to verify images that are captured in a medical imaging system have a diagnostic quality, to correct viewing characteristics of the image such as orientation, contrast, as well as to add annotations to mark significant finding or provide guidance for radiologists.
OmegaAI Image Viewer can store annotations and measurements as DICOM presentation states without changing the original image data. OmegaAI Image Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Computer-Aided Diagnosis (CAD) and AI software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). OmegaAl Image Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images. This can be used side by side with a reporting tool to create diagnostic reports.
Note: To protect confidential information and ensure data security, the OmegaAl Image Viewer has User Access Control (UAC) which prevents unauthorized access and modification of data.
OmegaAI Image Viewer runs in a web browser sand-box, thus it relies on the browser's handling of interruptions, low-memory conditions etc. The browser will give an error to the user when it is not able to an interruption.
Caution: Federal law restricts this device to sell by or on the order of a physician.
Device Description
OmegaAl Image Viewer is designed to view and manipulate medical images or videos created from diagnostic imaging systems such as X-ray, Computed tomography, Nuclear medicine, MRI, Ultrasound, laboratory systems, and images from other sources such as handheld devices and cameras, endoscopy or other sources of images and videos. It can perform various image manipulation activities and store the modifications as presentation state along with the original study for future reference. OmegaAI Image Viewer allows users to perform image manipulations using the Adjustment Tools, including window level, rotate, flip, pan, stack scroll, and magnify. Notably, users have access to Markup Tools such as annotate, angle, probe, Mark ROI, and measurement. OmegaAI Image Viewer is also capable of organizing all the captured images for a patient and presenting them in a zero-footprint, web user interface, allowing the users to view images in their preferred layout and enabling them to compare current images with prior images of the respective patient.
Available on popular mobile and desktop platforms with keyboard, mouse, and touch inputs, the OmegaAl I Image Viewer provides access to medical images in a convenient way for health care professionals to use as a diagnostic viewer and for review purposes.
OmegaAI Image Viewer supports major desktop and mobile browsers such as Microsoft Edge, Chrome, Safari, Apple iOS, Android, Windows and Mac devices. The software can only be used for diagnostic purposes on desktop platforms, whereas on mobile platforms it can be utilized as a non-diagnostic review tool by trained health professionals.
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