(112 days)
Not Found
No
The document describes a medical image viewer with standard image manipulation tools and does not mention any AI or ML capabilities.
No
The device is described as a software for displaying and manipulating medical images for diagnostic and review purposes, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is "intended for use as a primary diagnostic (on desktop platform)".
Yes
The device is described as a "software" application that provides access to and manipulation of medical images and associated documents. It is available on various desktop and mobile platforms and utilizes standard browsers and operating systems, indicating it is a software product that runs on existing hardware, rather than a dedicated hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this software "displays medical images and associated documents." It is used for viewing and manipulating medical images from various modalities (X-ray, CT, MRI, ultrasound, etc.).
- Lack of Biological Sample Analysis: There is no mention of the software analyzing biological samples or performing any kind of test on bodily fluids or tissues. Its function is solely related to the display and manipulation of pre-existing medical images.
Therefore, based on the provided text, this device falls under the category of medical image viewing and processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
View all image modalities, including X-ray, CT, MRI, color ultrasound and X-Ray angiography.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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)
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) |
|---|
| 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
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 |
| client (ZFP) | ||
| Manufacturer | RamSoft, Inc. | GE Healthcare |
| 510(k) Number | K141881 | K131977 |
| Regulation | ||
| 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 | |
| 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. | Centricity Universal Viewer Zero Footprint
client is a device that displays medical
images, data from various imaging
sources, and other healthcare information
sources. Medical images and data can be
viewed, communicated, processed and
displayed within a computer network or on
a workstation. The device may be used to
provide images for diagnostic purposes by
trained professionals.
Typical users of this system are authorized
individuals and trained healthcare
professionals who view medical images
and data.
Mammographic images may only be
interpreted using a monitor compliant with
requirements of local regulations and must
meet other technical specifications
reviewed and accepted by the local
regulatory agencies.
Contraindications:
Centricity Universal Viewer Zero Footprint
client is contraindicated for the use of lossy |
| Intended Use | Primary diagnostic (on desktop
platform) and non-diagnostic review
(on mobile platform) tool
This software is not suitable for
primary diagnosis of mammograms. | compressed mammographic images.
Lossy compressed mammographic images
and digitized film screen images must not
be reviewed for primary image
interpretations. |
| | | Use for the purpose of review, diagnostic
interpretation and post-diagnostic review of
medical images and reports. |
| Image
manipulation
features | Window/Level, Zoom, Rotation, Flip,
Pan, Measure, and Annotation. | Window/Level, Zoom/Pan, Flip/rotate,
Image |
| | RapidResults does not produce or
alter any images and medical data. | ZFP is a viewer that does not produce any
original medical images nor does it alter
any images or medical data. |
| HIPAA
Compliance | The Viewer secured connects to the
PACS using HTTPS | ZFP is an HTML 5 based viewer which
runs within a compatible web browser and
supports secure transmission of data. |
| | Images stay in the PACS, not on the
device. When the web browser or
mobile application is closed, all images
and information are gone from the
device. RapidResults does not store
images on any user's device. | |
| Support
Modalities | 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 image
storage, slide coordinates microscopic
image storage |
| Architecture | Server-based software solution that
display images and reports from a
PACS using a zero-footprint
application (HTML5), no installation
needed. | A zero-footprint application (HTML5) that
retrieve and display images and reports
from 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 that
requires zero installation, and zero
administrative rights required on the end
user's device |
| Support
Platforms,
Devices | Support major desktop and mobile
browsers such as Internet Explorer
10.0 or higher, Chrome, and Safari; on
Apple iOS, Android, Windows Mobile,
and Black Berry devices. | A PC, Mac®, or an iPad® can be used with
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.