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510(k) Data Aggregation
K Number
K141881Device Name
RAPIDRESULTS
Manufacturer
Date Cleared
2014-10-31
(112 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
This software displays medical images and associated documents. With appropriate display monitors, lighting, image quality, and level of lossy image compression, the software is intended for use as a primary diagnostic (on desktop platform) and non-diagnostic review tool (on mobile platform) for use by trained healthcare professionals. Each healthcare professional must determine if the level of loss is acceptable for their purpose. This software is not suitable for primary diagnosis of mammograms.
Device Description
RapidResults is a cutting edge application that provides of interactivity while maintaining the ease of use and security you've come to expect from RamSoft. Patient images and reports are available to view with zero footprint as there is no need to download special software. With RapidResults, the software allows users to perform image manipulations, including windowlevel, rotation, flip, zoom, panning, hanging protocol layout, measurement, localizer line, and study linking.
Available on popular mobile and desktop platforms with keyboard, mouse, and touch inputs, RapidResults provides access to medical images and associated documents in a convenient way for health care professionals to use as primary diagnostic and review tools.
RapidResults supports major desktop and mobile browsers such as Internet Explorer 10.0 or higher, Chrome, and Safari, Apple iOS, Android, Windows Mobile. It has been extensively tested with iOS (iPad Retina, iPad 2, and iPhone), Android (Galaxy Tab Pro, Galaxy Notes), Windows Mobile (Dell Latitude 10-ST2 Windows 8 Pro Tablet).
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K Number
K052460Device Name
POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE
Manufacturer
Date Cleared
2005-09-21
(14 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
This software is used with general purpose computing hardware for the storage, review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from imaging devices such as CR, CT, DX, MR, MG, NM, PT, RF, US, XA, film digitizers, and document scanners, and other DICOM devices. With appropriate hardware, the software is intended for use as a primary diagnostic, analysis, and review tool for use by trained healthcare professionals.
It is the user's responsibility to ensure image quality, lighting, and image compression ratios are suitable for the clinical application.
Digitized film should not be used for primary diagnosis in mammography. Lossy compression should not be used for primary diagnosis in mammography. Primary diagnosis on digital mammograms should not be done on any monitors other than those specifically cleared by the FDA for digital mammography applications. Film printing for digital mammography should not be performed on any printers other than those specifically cleared by the FDA for digital mammography applications.
Device Description
The PowerServer software suite is used on general purpose computing hardware and includes the following components: PowerServer, PowerReader, Gateway, and PowerCache. As long as minimum hardware and operating system requirements are met, the user or system integrator is free to choose his/her own hardware platform.
PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage, archiving, retrieval, and transmission, and communicates with other DICOM devices. The system also communicates with PowerReader workstations and PowerCache servers. Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state. PowerCache is a caching server that communicates with PowerServer and serves PowerReader workstations. A single PowerCache can serve multiple PowerReader workstations, reducing network traffic between PowerReader workstations and PowerServer.
PowerReader is a workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data stored on PowerServer and PowerCache. PowerReader can connect directly to PowerServer and can also connect via PowerCache. PowerReader provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.
Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.
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K Number
K031562Device Name
RAMSOFT PACS, MODEL 3.0
Manufacturer
Date Cleared
2003-08-11
(84 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
RamSoft PACS software is used with general purpose computing hardware to acquire, transmit, store and display images for clinical purposes. RamSoft PACS consists of one or more of image server, web server, database server, and workstations for interpretation, clinical review, quality control, video capturing, film digitizing, document scanning. Images may be acquired from imaging devices such as CR, CT, DX, MR, NM, PT, RF, US, XA, and other devices.
Device Description
RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication, and storage.
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K Number
K982563Device Name
ULTRAPRO MODEL 98
Manufacturer
Date Cleared
1998-10-06
(75 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
Ultrapro is a system that utilizes standard personal computer hardware to acquire, display, communicate and archive diagnostic images. The system is designed for use by medical professionals to acquire data from FDA listed imaging equipment such as ultrasound, CT and MRJ scanners, x-ray imagers and video cassette recorders that provide a video output or a digital output. Archival is to be performed on media that is FDA listed.
Ultrapro can be configured to use JPEG lossy compression. When lossy compression is used, the compression ratio will be imprinted in the non-diagnostic area of the image. The compression ratio can be adjusted during acquisition.
Device Description
Ultrapro is a tool for a medical imaging practice. It can acquire medical images from any standard medical video source. Digital data in the DICOM format or other popular PC formats such as JPEG, TIFF, etc. can also be acquired.
Images may be acquired in uncompressed or compressed format (lossless or lossy). The lossy compression ratio is selected by viewing the original image and the lossy compressed image side by side and increasing the ratio while retaining clinically significant characteristics. Images that have been lossy compressed have the text "LOSSY xx:1" where xx is the compression ratio placed in the visible, non-diagnostic area of the image.
Related patient information can also be entered or scanned in with a TWAIN compliant scanner. Once acquired, Ultrapro serves as a digital storage for these images. Images are stored on the computer. Images may be communicated to other Ultrapro workstations or to third-party DICOM 3.0 compliant PACS components. The radiologist may review the images with Ultrapro and create reports. The display of images (contrast, brightness, zoom, etc.) may be adjusted at any time. Annotations may be drawn on images. Distance measurements may be made on images. These image parameters may be saved along with the image while still preserving the original image. This information can be communicated to other workstations through a network or modem. Finally, all of the information may be archived onto optical media for permanent storage.
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