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).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the device "RapidResults" by RamSoft, Inc. The document aims to demonstrate substantial equivalence to a predicate device, focusing on its intended use as a medical image display and review tool.

However, the provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or the methodology of such a study. The document primarily focuses on establishing substantial equivalence to a predicate device (Centricity Universal Viewer Zero Footprint client, K131977) by comparing general characteristics and intended uses.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies based solely on the provided text.

The closest information related to "performance" is a general description of the device's functionality and a comparison of features with the predicate device, but not quantitative performance against pre-defined acceptance criteria.

Key points from the document that are relevant to the requested categories (but lack the specific details you're looking for):

Device Name: RapidResults
Intended Use: Primary diagnostic (on desktop platform) and non-diagnostic review tool (on mobile platform) for medical images and associated documents. Not suitable for primary diagnosis of mammograms.
Predicate Device: Centricity Universal Viewer Zero Footprint client (ZFP) - K131977
Testing Mentioned: "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)." This refers to compatibility testing, not a clinical performance study.
HIPAA Compliance: The viewer "secured connects to the PACS using HTTPS" and "Images stay in the PACS, not on the device."

To answer your request, I would need a different type of document, such as a detailed design validation report or a clinical study report, which would typically be submitted as part of the 510(k) submission but are not included in this summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31, 2014

RamSoft, Inc. % Mr. Lely Lam-Hong Director of Quality Assurance 243 College Street, Suite 100 TORONTO ON M5T 1R5 CANADA

Re: K141881 Trade/Device Name: RapidResults Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 29, 2014 Received: September 8, 2014

Dear Mr. Lam-Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Smh.f)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141881

Device Name RapidResults

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for RamSoft. The word "Ram" is in red, and the word "Soft" is in black. The font is sans-serif and bold.

510(k) Summary

Statement

The following information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements..." (21 CFR 807.92) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency

General Company Information

Company: RamSoft, Inc. Contact: Lely Lam-Hong 243 College St, Suite 100, Toronto, ON M5T 1R5, Canada Address: Phone: +1-(416)-674-1347 +1-(416)-674-7147 Fax: lhong@ramsoft.com Email:

Date Prepared: June 30, 2014.

General Device Description

Common Name: Universal PACS Viewer Trade Name: RapidResults Classification: Class II, Produce Code LLZ

Predicate Devices

510(k) Number: K131977 Device Name: Centricity Universal Viewer Zero Footprint client (ZFP) Company: GE Healthcare

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RamSoft

Indication for Use

Comparison with the Predicate Devices

Characteristics	Subject Device	Predicate Devices
Device Name	RapidResults	Centricity Universal Viewer Zero Footprintclient (ZFP)
Manufacturer	RamSoft, Inc.	GE Healthcare
510(k) Number	K141881	K131977
RegulationNumber, Class	21 CFR 892.2050, Class II	21 CFR 892.2050, Class II
Product Code	LLZ	LLZ
Indication for Use	This software displays medical imagesand associated documents.With appropriate display monitors,lighting, image quality, and level oflossy image compression, the softwareis intended for use as a primarydiagnostic (on desktop platform) andnon-diagnostic review tool (on mobileplatform) for use by trained healthcareprofessionals.Each healthcare professional mustdetermine if the level of loss isacceptable for their purpose.This software is not suitable forprimary diagnosis of mammograms.	Centricity Universal Viewer Zero Footprintclient is a device that displays medicalimages, data from various imagingsources, and other healthcare informationsources. Medical images and data can beviewed, communicated, processed anddisplayed within a computer network or ona workstation. The device may be used toprovide images for diagnostic purposes bytrained professionals.Typical users of this system are authorizedindividuals and trained healthcareprofessionals who view medical imagesand data.Mammographic images may only beinterpreted using a monitor compliant withrequirements of local regulations and mustmeet other technical specificationsreviewed and accepted by the localregulatory agencies.Contraindications:Centricity Universal Viewer Zero Footprintclient is contraindicated for the use of lossy
Intended Use	Primary diagnostic (on desktopplatform) and non-diagnostic review(on mobile platform) toolThis software is not suitable forprimary diagnosis of mammograms.	compressed mammographic images.Lossy compressed mammographic imagesand digitized film screen images must notbe reviewed for primary imageinterpretations.
		Use for the purpose of review, diagnosticinterpretation and post-diagnostic review ofmedical images and reports.
Imagemanipulationfeatures	Window/Level, Zoom, Rotation, Flip,Pan, Measure, and Annotation.	Window/Level, Zoom/Pan, Flip/rotate,Image
	RapidResults does not produce oralter any images and medical data.	ZFP is a viewer that does not produce anyoriginal medical images nor does it alterany images or medical data.
HIPAACompliance	The Viewer secured connects to thePACS using HTTPS	ZFP is an HTML 5 based viewer whichruns within a compatible web browser andsupports secure transmission of data.
	Images stay in the PACS, not on thedevice. When the web browser ormobile application is closed, all imagesand information are gone from thedevice. RapidResults does not storeimages on any user's device.
SupportModalities	View all image modalities, including X-ray, CT, MRI, color ultrasound and X-Ray angiography.	Single-frame and enhanced CT, MR, US,PT, XA, RF, SC Images
		CR, DX, MG, IO, SC, XA, VL endoscopic,microscopic, and photographic imagestorage, slide coordinates microscopicimage storage
Architecture	Server-based software solution thatdisplay images and reports from aPACS using a zero-footprintapplication (HTML5), no installationneeded.	A zero-footprint application (HTML5) thatretrieve and display images and reportsfrom a PACS
Technology	Use of various technology standards(LDAP, SSO, HTTPS, HTML, HTML5,CSS, XML, web services, etc.)	The ZFP is a true HTML5 application thatrequires zero installation, and zeroadministrative rights required on the enduser's device
SupportPlatforms,Devices	Support major desktop and mobilebrowsers such as Internet Explorer10.0 or higher, Chrome, and Safari; onApple iOS, Android, Windows Mobile,and Black Berry devices.	A PC, Mac®, or an iPad® can be used witha variety of browsers

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Image /page/6/Picture/0 description: The image shows the word "RamSoft" in a bold, sans-serif font. The "R" in "Ram" is red, while the rest of the letters are black. The letters are large and take up most of the image.

Conclusion

Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the subject device is sustainably equivalent to the predicated devices (K131977) under the Federal Food, Drug and Cosmetic Act.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).