RAPIDRESULTS

K141881 · Ramsoft, Inc. · LLZ · Oct 31, 2014 · Radiology

Device Facts

• Record ID: K141881
• Device Name: RAPIDRESULTS
• Applicant: Ramsoft, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 Story

RapidResults is a zero-footprint, server-based PACS viewer; enables access to medical images and reports via web browsers on desktop and mobile platforms. Inputs: medical images/documents from PACS. Operation: HTML5-based application; allows image manipulation (window/level, rotation, flip, zoom, pan, measurement, hanging protocols, study linking). Outputs: visual display of images/reports on user device. Used by healthcare professionals in clinical settings; images remain on server, not stored on local device. Enhances clinical workflow by providing convenient, secure (HTTPS) access to diagnostic data; supports decision-making through remote image review.

Clinical Evidence

No clinical data provided; bench testing only. Device functionality verified through performance testing of image manipulation tools, browser compatibility, and secure data transmission.

Technological Characteristics

Zero-footprint, server-based software; HTML5/web-based architecture. Connectivity via HTTPS; supports LDAP and SSO. Compatible with major browsers (IE 10+, Chrome, Safari) on desktop and mobile platforms (iOS, Android, Windows Mobile). No local image storage; images retrieved from PACS.

Indications for Use

Indicated for trained healthcare professionals to display and review medical images and associated documents. Desktop platform use is for primary diagnosis; mobile platform use is for non-diagnostic review. Contraindicated for primary diagnosis of mammograms.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Centricity Universal Viewer Zero Footprint client (ZFP) (K131977)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

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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: [phone] [phone] Fax: [e-mail] Email:

Date Prepared: June 30, 2014.

#### General 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).

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

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.

# Comparison with the Predicate Devices

| Characteristics | Subject Device | Predicate Devices |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | RapidResults | Centricity Universal Viewer Zero Footprint<br>client (ZFP) |
| Manufacturer | RamSoft, Inc. | GE Healthcare |
| 510(k) Number | K141881 | K131977 |
| Regulation<br>Number, Class | 21 CFR 892.2050, Class II | 21 CFR 892.2050, Class II |
| Product Code | LLZ | LLZ |
| Indication for Use | This software displays medical images<br>and associated documents.<br><br>With appropriate display monitors,<br>lighting, image quality, and level of<br>lossy image compression, the software<br>is intended for use as a primary<br>diagnostic (on desktop platform) and<br>non-diagnostic review tool (on mobile<br>platform) for use by trained healthcare<br>professionals.<br><br>Each healthcare professional must<br>determine if the level of loss is<br>acceptable for their purpose.<br><br>This software is not suitable for<br>primary diagnosis of mammograms. | Centricity Universal Viewer Zero Footprint<br>client is a device that displays medical<br>images, data from various imaging<br>sources, and other healthcare information<br>sources. Medical images and data can be<br>viewed, communicated, processed and<br>displayed within a computer network or on<br>a workstation. The device may be used to<br>provide images for diagnostic purposes by<br>trained professionals.<br><br>Typical users of this system are authorized<br>individuals and trained healthcare<br>professionals who view medical images<br>and data.<br><br>Mammographic images may only be<br>interpreted using a monitor compliant with<br>requirements of local regulations and must<br>meet other technical specifications<br>reviewed and accepted by the local<br>regulatory agencies.<br><br>Contraindications:<br>Centricity Universal Viewer Zero Footprint<br>client is contraindicated for the use of lossy |
| Intended Use | Primary diagnostic (on desktop<br>platform) and non-diagnostic review<br>(on mobile platform) tool<br>This software is not suitable for<br>primary diagnosis of mammograms. | compressed mammographic images.<br>Lossy compressed mammographic images<br>and digitized film screen images must not<br>be reviewed for primary image<br>interpretations. |
| | | Use for the purpose of review, diagnostic<br>interpretation and post-diagnostic review of<br>medical images and reports. |
| Image<br>manipulation<br>features | Window/Level, Zoom, Rotation, Flip,<br>Pan, Measure, and Annotation. | Window/Level, Zoom/Pan, Flip/rotate,<br>Image |
| | RapidResults does not produce or<br>alter any images and medical data. | ZFP is a viewer that does not produce any<br>original medical images nor does it alter<br>any images or medical data. |
| HIPAA<br>Compliance | The Viewer secured connects to the<br>PACS using HTTPS | ZFP is an HTML 5 based viewer which<br>runs within a compatible web browser and<br>supports secure transmission of data. |
| | Images stay in the PACS, not on the<br>device. When the web browser or<br>mobile application is closed, all images<br>and information are gone from the<br>device. RapidResults does not store<br>images on any user's device. | |
| Support<br>Modalities | View all image modalities, including X-<br>ray, CT, MRI, color ultrasound and X-<br>Ray angiography. | Single-frame and enhanced CT, MR, US,<br>PT, XA, RF, SC Images |
| | | CR, DX, MG, IO, SC, XA, VL endoscopic,<br>microscopic, and photographic image<br>storage, slide coordinates microscopic<br>image storage |
| Architecture | Server-based software solution that<br>display images and reports from a<br>PACS using a zero-footprint<br>application (HTML5), no installation<br>needed. | A zero-footprint application (HTML5) that<br>retrieve and display images and reports<br>from a PACS |
| Technology | Use of various technology standards<br>(LDAP, SSO, HTTPS, HTML, HTML5,<br>CSS, XML, web services, etc.) | The ZFP is a true HTML5 application that<br>requires zero installation, and zero<br>administrative rights required on the end<br>user's device |
| Support<br>Platforms,<br>Devices | Support major desktop and mobile<br>browsers such as Internet Explorer<br>10.0 or higher, Chrome, and Safari; on<br>Apple iOS, Android, Windows Mobile,<br>and Black Berry devices. | A PC, Mac®, or an iPad® can be used with<br>a 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.