(131 days)
The Rology Teleradiology Platform is a Web-based software system used to receive, view and manipulate DICOM images, schedule, provide textual reports, organize, store, and make such information available.
When images are reviewed and used as an element of diagnosis, it is the responsibility of the qualified clinician to determine if the image quality is suitable for their clinical application.
The Rology Teleradiology Platform is intended to be used by clinicians qualified in the use of radiological images for interpretation/diagnosis.
Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis.
Rology Teleradiology Platform developed by Rology Inc. is a Software as a Medical Device (SaMD) system used to receive DICOM images, schedule information, and textual reports, organize and store them in an internal format, and make that information available across a network via web and customized user interfaces.
The Rology Teleradiology Platform is intended to be used by trained and qualified healthcare professionals, including radiologists, technologists, and medical professionals, in hospitals, clinics, and medical imaging centers, to aid the radiologists in reading, interpreting, and reporting. When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained radiologist to determine if the image quality is suitable for their clinical application, so the radiologist retains the ultimate responsibility for making the final diagnosis decision.
Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis.
Rology Teleradiology Platform is designed to integrate with current medical systems through standard medical protocols:
- . DICOM: for exchanging medical imaging.
- HL7/FHIR: for exchanging electronic health records .
The Rology Teleradiology Platform is to be used to view DICOM-compliant studies, which are stored in the cloud using to AWS's S3 service and is intended for professional use only as a viewing tool for medical image studies. The Rology Teleradiology Platform is comprised of the following modules/functions:
- Acquiring studies by the Rology Connect module which allows for the automatic . acquisition of images from DICOM-compliant devices. It receives, anonymizes, compresses, and uploads the studies to the platform using AWS's S3 service. A third-party DICOM device sends the images to the Rology DICOM node, which will extract DICOM data and upload the images to cloud servers.
- Scheduling and organizing studies after being uploaded by the Workflow Manager. .
- View DICOM-compliant studies using the DICOM Viewer software which will fetch . images and data from backend servers, to allow users to view those images on their personal computers, to diagnose, manipulate, and interpret the studies.
- Report textual/transmission to the healthcare facility using the Reporting Tool which is part of the DICOM Viewer, to Incorporate non-image data, such as scanned documents, using consumer industry standard formats like PDF (Portable Document Format). The report will be sent securely to the healthcare facility for review/acceptance.
The features and functions of Rology DICOM Viewer module, which includes Viewer technology and features include:
General Functions:
- . Receive DICOM images from the acquisition device
- . Textual reports, and transmit the reports securely to the hospital
- Store images in a secure cloud environment .
Basic Imaging functions:
- Grayscale Image Rendering ●
- Localizer Lines ●
- Localizer Point .
- Distance Markers ●
- Study Data Overlays ●
- Stack Navigation Tool ●
- Window/Level Tool
- Zoom Tool ●
- . Panning Tool
- Clockwise/Counterclockwise Rotation .
- Color Inversion ●
- Area Measurement Annotation ●
- Angle Measurement Annotation ●
- . Added keyboard shortcuts for some tools
- Orientation Markers
Advanced imaging functions
- Multi-Planar Reconstruction (MPR) •
- . Maximum Intensity Projection (MIP)
The Rology DICOM Viewer module is the only 'module' of the system that is believed to meet the definition of being a regulated medical device. The other modules of the Rology Teleradiology Platform are included to provide a complete understanding of the software system and its interactions with the intended user(s).
Here's a breakdown of the acceptance criteria and study information for the Rology Teleradiology Platform, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets. Instead, the document describes the testing as "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" The reported performance is a simple "Pass" for each test.
| Performance Test | Reported Device Performance |
|---|---|
| User Interface/Input | Pass |
| Drag and Drop Import | Pass |
| Image Storage | Pass |
| Textual Reports | Pass |
| Database software | Pass |
| Grayscale Image Rendering | Pass |
| RGB Image Rendering | Pass |
| Distance Markers | Pass |
| Study Data Overlays | Pass |
| Stack Navigation Tool | Pass |
| Window Level | Pass |
| Zoom in on the Image | Pass |
| Panning | Pass |
| Invert image | Pass |
| Text Annotation | Pass |
| MIP/MPR Reconstruction | Pass |
| Area Measurement Annotation | Pass |
| Angle Measurement Annotation | Pass |
| User Interface text styles, colors, fonts, and icons. | Pass |
| WebGL Rendering Optimizations | Pass |
| Support for high-resolution Retina displays | Pass |
| Keyboard shortcuts | Pass |
| Localizer Lines | Pass |
| Localizer Point | Pass |
| Color Inversion | Pass |
| Orientation Markers | Pass |
| Clockwise/Counterclockwise Rotation | Pass |
| Search | Pass |
| Cobb Angle Measurement Annotation | Pass |
| Thumbnail viewing | Pass |
| Automatic Upload | Pass |
| Worklist | Pass |
| Download Report | Pass |
| Recheck | Pass |
| Pick up studies | Pass |
| Side-by-side Comparison | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply mentions that "The performance testing (design verification and design validation) verified that the design requirements were successfully met."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was conducted or reported for the Rology Teleradiology Platform in this submission. The device is a teleradiology platform, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was conducted. The Rology Teleradiology Platform is a software system intended to be used by qualified clinicians for viewing and manipulating images, with the clinician retaining ultimate responsibility for diagnosis.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The performance testing appears to be centered around verifying functional requirements rather than diagnostic accuracy against a clinical ground truth. The statement that "The Intended use and user needs were successfully validated using appropriate validation partners representing the intended users of the Rology Teleradiology Platform" suggests user acceptance testing for functionality.
8. Sample Size for the Training Set
The document does not mention a training set. The Rology Teleradiology Platform is described as a "Software as a Medical Device (SaMD) system used to receive DICOM images, schedule information, and textual reports, organize and store them... and make that information available," which suggests it's primarily an image management and viewing system, not an AI/ML diagnostic algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI/ML algorithm, there is no information about how its ground truth was established.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Rology Inc. % James Luker VP of Regulatory Affairs Innolitics, LLC 1101 West 34th Street, #550 AUSTIN TX 78705
September 20, 2023
Re: K231385
Trade/Device Name: Rology Teleradiology Platform (v.1.22.1103) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 11, 2023 Received: August 14, 2023
Dear James Luker:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231385
Device Name Rology Teleradiology Platform
Indications for Use (Describe)
The Rology Teleradiology Platform is a Web-based software system used to receive, view and manipulate DICOM images, schedule, provide textual reports, organize, store, and make such information available.
When images are reviewed and used as an element of diagnosis, it is the responsibility of the qualified clinician to determine if the image quality is suitable for their clinical application.
The Rology Teleradiology Platform is intended to be used by clinicians qualified in the use of radiological images for interpretation/diagnosis.
Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis.
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 a blue logo with a stylized letter 'R' inside a square frame. The 'R' is formed by a curved line at the top and two horizontal lines at the bottom, resembling a river. The letters 'TM' are located in the upper right corner of the 'R', indicating a trademark. The logo is simple, modern, and uses a single color.
510(k) Summary
1. ADMINISTRATIVE INFORMATION
| Submitter Name | Rology Inc. |
|---|---|
| Address | 1202 NE McClain Road, Bldg 7, Bentonville, Arkansas, 72712,United States of America |
| Phone Number | 302 561 9511 |
| Fax Number | N/A |
| Company Representative | Amr Abodraiaa |
| amr.abodraiaa@rology.net | |
| Primary Contact | Jim Luker |
| Primary Contact PhoneNumber | 321 205 3104 |
| Primary Contact Email | JLuker@Innolitics.com |
| Date Summary Prepared | September 15, 2023 |
2. SUBJECT DEVICE INFORMATION
| Trade Name | Rology Teleradiology Platform |
|---|---|
| 510(k) # | K231385 |
| CommonName | Medical image management and processing system |
| Product Code | LLZ |
| RegulationNumber | 892.2050 |
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Image /page/4/Picture/0 description: The image shows a blue logo with a stylized letter 'R' inside a square frame. The 'R' is formed by a curved line at the top and two horizontal lines below, resembling waves. The 'TM' symbol is located in the upper right corner of the 'R', indicating a trademark.
510(k) Summary
| ClassificationName | System, Image Processing, Radiological |
|---|---|
| RegulatoryClass | Class 2 |
| Review Panel | Radiology |
| Indications | The Rology Teleradiology Platform is a Web-based software system used toreceive, view and manipulate DICOM images, schedule, provide textualreports, organize, store, and make such information available.When images are reviewed and used as an element of diagnosis, it is theresponsibility of the qualified clinician to determine if the image quality issuitable for their clinical application.The Rology Teleradiology Platform is intended to be used by cliniciansqualified in the use of radiological images for interpretation/diagnosis.Contraindications: Rology Teleradiology Platform is not intended for theacquisition of mammographic image data for primary diagnosis. |
3. PREDICATE DEVICE INFORMATION
The Braid device (K200822) has been selected as the primary predicate device because it has equivalent intended use, indications and functions as compared to the Rology Teleradiology Platform. Both devices also have the following similar function:
- MIP/MPR Reconstruction .
The following information relates to the predicate device:
| Trade Name | Braid |
|---|---|
| 510(k) Number | K200822 |
| Common Name | Picture archiving and communications system |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
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Image /page/5/Picture/0 description: The image shows a logo with a blue square outline. Inside the square is a stylized letter 'R' that also resembles a wave. The 'R' is also blue, and there is a 'TM' symbol in the upper right corner of the square, indicating a trademark.
510(k) Summary
| Classification Name | System, Image Processing, Radiological |
|---|---|
| Regulatory Class | Class 2 |
| Review Panel | Radiology |
4. REFERENCE DEVICE INFORMATION
The BOX DICOM Viewer (K151957) has been selected as a reference device to support the following functions which are not included in the Braid predicate device:
- Support for PET images
- Cobb Angle measurement
It is noted that the Braid device used the BOX DICOM Viewer as the predicate device in its 510(k) submission.
The following information relates to the reference device:
| Trade Name | BOX DICOM Viewer |
|---|---|
| 510(k) Number | K151957 |
| Common Name | Picture archiving and communications system |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
| Classification Name | System, Image Processing, Radiological |
| Regulatory Class | Class 2 |
| Review Panel | Radiology |
5. DEVICE DESCRIPTION
Rology Teleradiology Platform developed by Rology Inc. is a Software as a Medical Device (SaMD) system used to receive DICOM images, schedule information, and textual reports, organize and store them in an internal format, and make that information available across a network via web and customized user interfaces.
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Image /page/6/Picture/0 description: The image shows a blue logo with a stylized letter 'R' inside a square. The 'R' is formed by a curved line at the top and two wavy lines below, resembling water. A small 'TM' symbol is placed to the right of the upper curve of the 'R', indicating a trademark. The logo has a clean and modern design.
ROLOGY TELERADIOLOGY PLATFORM (K231385) 510(k) Summary
The Rology Teleradiology Platform is intended to be used by trained and qualified healthcare professionals, including radiologists, technologists, and medical professionals, in hospitals, clinics, and medical imaging centers, to aid the radiologists in reading, interpreting, and reporting. When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained radiologist to determine if the image quality is suitable for their clinical application, so the radiologist retains the ultimate responsibility for making the final diagnosis decision.
Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis.
Rology Teleradiology Platform is designed to integrate with current medical systems through standard medical protocols:
- . DICOM: for exchanging medical imaging.
- HL7/FHIR: for exchanging electronic health records .
The Rology Teleradiology Platform is to be used to view DICOM-compliant studies, which are stored in the cloud using to AWS's S3 service and is intended for professional use only as a viewing tool for medical image studies. The Rology Teleradiology Platform is comprised of the following modules/functions:
- Acquiring studies by the Rology Connect module which allows for the automatic . acquisition of images from DICOM-compliant devices. It receives, anonymizes, compresses, and uploads the studies to the platform using AWS's S3 service. A third-party DICOM device sends the images to the Rology DICOM node, which will extract DICOM data and upload the images to cloud servers.
- Scheduling and organizing studies after being uploaded by the Workflow Manager. .
- View DICOM-compliant studies using the DICOM Viewer software which will fetch . images and data from backend servers, to allow users to view those images on their personal computers, to diagnose, manipulate, and interpret the studies.
- Report textual/transmission to the healthcare facility using the Reporting Tool which is part of the DICOM Viewer, to Incorporate non-image data, such as scanned documents, using consumer industry standard formats like PDF (Portable Document Format). The report will be sent securely to the healthcare facility for review/acceptance.
The features and functions of Rology DICOM Viewer module, which includes Viewer technology and features include:
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Image /page/7/Picture/0 description: The image shows a blue logo with a stylized letter 'R' inside a square. The 'R' is formed by a curved line at the top and two horizontal lines at the bottom, resembling waves. A small 'TM' symbol is located in the upper right corner of the 'R', indicating a trademark. The logo has a clean and modern design.
510(k) Summary
General Functions:
- . Receive DICOM images from the acquisition device
- . Textual reports, and transmit the reports securely to the hospital
- Store images in a secure cloud environment .
Basic Imaging functions:
- Grayscale Image Rendering ●
- Localizer Lines ●
- Localizer Point .
- Distance Markers ●
- Study Data Overlays ●
- Stack Navigation Tool ●
- Window/Level Tool
- Zoom Tool ●
- . Panning Tool
- Clockwise/Counterclockwise Rotation .
- Color Inversion ●
- Area Measurement Annotation ●
- Angle Measurement Annotation ●
- . Added keyboard shortcuts for some tools
- Orientation Markers
Advanced imaging functions
- Multi-Planar Reconstruction (MPR) •
- . Maximum Intensity Projection (MIP)
The Rology DICOM Viewer module is the only 'module' of the system that is believed to meet the definition of being a regulated medical device. The other modules of the Rology Teleradiology Platform are included to provide a complete understanding of the software system and its interactions with the intended user(s).
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Image /page/8/Picture/0 description: The image shows a logo with a stylized letter 'R' inside a square frame. The 'R' is formed by a curved line at the top and two wavy lines below, resembling a river. The logo is in a bright blue color, and there is a 'TM' symbol in the upper right corner of the square, indicating a trademark.
510(k) Summary
6. DEVICE COMPARISON TABLE
The subject and predicate device have equivalent technological characteristics. Additional technological characteristics are supported by a reference device. A comparison is provided in the table below.
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957 | Comments |
|---|---|---|---|---|
| Applicant | Rology, Inc. | Braid.Health | BOX, Inc | N/A |
| Device Name | RologyTeleradiologyPlatform | Braid | BOXDICOMViewer | N/A |
| Product Code | LLZ | LLZ | LLZ | Same |
| Regulation Number | 21 CFR 892.2050 | 21 CFR892.2050 | 21 CFR892.2050 | Same |
| IntendedUse/Indications forUse | The RologyTeleradiologyPlatform is a Web-based softwaresystem used toreceive, view andmanipulateDICOM images,schedule, providetextual reports,organize, store,and make suchinformationavailable.When images arereviewed and used | Braid is asoftwareteleradiologysystem used toreceive DICOMimages,schedulinginformation andtextual reports,organize andstore them in aninternal format,and to make thatinformationavailable acrossa network via | The BOXDICOMViewer isa softwareTeleradiologysystemused toreceiveDICOMimages,schedulinginformation andtextual | The proposedindications forthe RologyTeleradiologyPlatform areequivalent toBraidpredicatedevice withthe exceptionof support forPET imagesand CobbAnglecalculation.Both of these |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| as an element ofdiagnosis, it is theresponsibility ofthe qualifiedclinician todetermine if theimage quality issuitable for theirclinicalapplication.The RologyTeleradiologyPlatform isintended to beused by cliniciansqualified in the useof radiologicalimages forinterpretation/diagnosis.Contraindications:RologyTeleradiologyPlatform is notintended for theacquisition ofmammographicimage data forprimary diagnosis. | web. Braid isused byhospitals, clinics,imaging centers,and radiologistreadingpractices. Braidcan optionally beused for mobilediagnostic usefor review andanalysis of CR,DX, CT, and MRimages andmedical reports.Braid mobilediagnostic use isnot intended toreplace fulldiagnosticworkstations andshould only beused when thereis no access to aworkstation.Braid mobilediagnostic use isnot intended forthe display ofmammographyimages fordiagnosis. Whenimages are | reports,organizeand storethem in aninternalformat,and tomake thatinformationavailableacross anetworkvia webandcustomized userinterfaces.The BOXDICOMViewer isused byhospitals,imagingcenters,radiologistreadingpractice.Contraindications:The BOXDICOMViewer is | functions arepresent in theBOX DICOMViewerreferencedevice.Additionally,the RologyTeleradiologyPlatform hasthe sameintended useas both thepredicate andreferencedevice. Allthree devicesare intendedto be used toreceiveDICOMimages,scheduleinformationand textualreports,organize andstore them inan internalformat, and tomake thatinformationavailable | |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| reviewed and useas an element ofdiagnosis, it isthe responsibilityof the trainedphysician todetermine if theimage quality issuitable for theirclinicalapplication.Contraindications: Braid is notintended for theacquisition ofmammographicimage data and ismeant to be usedby qualifiedmedicalpersonnel onlywho are qualifiedto create anddiagnoseradiologicalimage data. | notintendedfor theacquisition ofmammographicimagedata and ismeant tobe used byqualifiedmedicalpersonnelonly whoarequalifiedto createanddiagnoseradiological imagedata. | across anetwork viaweb. | ||
| Intended user | Radiologists &Qualified medicalpersonnel | Radiologists &Qualifiedmedicalpersonnel | Radiologists &Qualifiedmedicalpersonnel | Same |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| Acquisition devices | CR, DX, CT, MR,US, PET | CR, DX, CT,MR | CT, MR,US, PET | RologyTeleradiologyPlatformsupports PETand USimages asdoes the BOXDICOMViewerreferencedevice. |
| Communication | DICOM | DICOM | DICOM | Same |
| Network Access | Web browser | Web browser | Webbrowser | Same |
| Web BrowserSoftware | Google Chrome | Google Chrome,Safari | GoogleChromefor allfeatures.MicrosoftInternetExplorer& MozillaFirefoxforfeaturesexcept theDICOMViewer. | Equivalent -each productsupports theGoogleChromeinternetbrowser. |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| Mobile Platforms | None | iPhones, iPads | None | The RologyTeleradiologyPlatform doesnot supportmobileplatforms.This isequivalent tothe referencedevice. Thelack ofsupport formobileplatformsdoes not adddifferentquestionsrelated tosafety oreffectiveness. |
| User Interface/Input | Mouse andkeyboard | Mouse keyboard,andTouchscreens | Mouseandkeyboard | Equivalentinput type.The RologyTeleradiologyPlatform doesnot supporttouchscreenuse. This isequivalent tothe referencedevice. Thelack of |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| support fortouchscreenuse does notadd differentquestionsrelated tosafety oreffectiveness. | ||||
| Drag and Drop Import | No | Yes | Yes | The subjectdevice doesnot have thisfeature, butthe absence ofthis featuredoes not raisequestions ofsafety andeffectivenessor affect theintended useof the device. |
| Image Storage | Yes | Yes | Yes | Same |
| Textual Reports | Yes | Yes | No | Same as thepredicatedevice |
| Database software | MongoDB | CouchDB,IndexedDB,LevelDB | MySQL | MongoDB isan alternativeto CouchDB,IndexedDB,LevelDB, and |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| MySQLdatabasesoftware,which canprovide thesamefunctionalities | ||||
| Grayscale ImageRendering | Yes | Yes | Yes | Same |
| RGB ImageRendering | No | No | Yes | Same as thepredicatedevice |
| Distance Markers | Yes | Yes | Yes | Same |
| Study Data Overlays | Yes | Yes | Yes | Same |
| Stack Navigation Tool | Yes | Yes | Yes | Same |
| Window Level | Yes | Yes | Yes | Same |
| Zoom in on the Image | Yes | Yes | Yes | Same |
| Panning | Yes | Yes | Yes | Same |
| Invert image | Yes | Yes | Yes | Same |
| Text Annotation | Yes | Yes | Yes | Same |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| MIP/MPRReconstruction | Yes | Yes | No | Same as thepredicatedevice |
| Area MeasurementAnnotation | Yes | Yes | Yes | Same |
| Angle MeasurementAnnotation | Yes | Yes | Yes | Same |
| User Interface textstyles, colors, fonts,and icons. | None | None | BOXStyles | Same as thepredicatedevice |
| WebGL RenderingOptimizations | Yes | Yes | Yes | Hardwareacceleration isused. WebGL(WebGraphicsLibrary) is aJavaScriptAPI forrenderinginteractive 3Dcomputergraphics and2D graphicswithin anycompatibleweb browserwithout theuse of plug-ins. |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| of thistechnologyraises no newquestions ofsafety andeffectivenessand issupported byperformancetesting. | ||||
| Support for high-resolution Retinadisplays | Full pixel densityon all displays | Full pixel densityon all displays | Full pixeldensity onalldisplays | Same |
| Keyboard shortcuts | Yes | Yes | Yes | Same |
| Localizer Lines | Yes | Yes | Yes | Same |
| Localizer Point | Yes | Yes | Yes | Same |
| Color Inversion | Yes | Yes | Yes | Same |
| Orientation Markers | Yes | Yes | Yes | Same |
| Clockwise/Counterclockwise Rotation | Yes | Unknown | Yes | Equivalent tothe referencedevice |
| Search | Yes | Unknown | Yes | Equivalent tothe referencedevice |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| Cobb AngleMeasurementAnnotation | Yes | Unknown | Yes | Equivalent tothe referencedevice |
| Thumbnail viewing | Yes | Unknown | Yes | Equivalent tothe referencedevice |
| Automatic Upload | Yes | No | No | The additionof this featureraises no newquestions ofsafety andeffectivenessand issupported byperformancetesting |
| Worklist | Yes | Unknown | Yes | Equivalent tothe referencedevice |
| Download Report | Yes | Unknown | Unknown | The additionof this featureraises no newquestions ofsafety andeffectivenessand issupported byperformancetesting |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| Recheck | Yes | No | No | The additionof this featureraises no newquestions ofsafety andeffectivenessand issupported byperformancetesting |
| Pick up studies | Yes | No | No | The additionof this featureraises no newquestions ofsafety andeffectivenessand issupported byperformancetesting |
| Side-by-sideComparison | Yes | Unknown | Unknown | The additionof this featureraises no newquestions ofsafety andeffectivenessand issupported byperformancetesting |
| Feature/Function | Subject Device:RologyTeleradiologyPlatform | PredicateDevice: Braid(K200822) | ReferenceDevice:BOXDICOMViewer(K151957) | Comments |
| Play | Yes | Unknown | Unknown | The additionof this featureraises no newquestions ofsafety andeffectivenessand issupported byperformancetesting. |
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Image /page/9/Picture/0 description: The image shows a blue logo with a stylized letter 'R' inside a square frame. The 'R' is formed by a curved line at the top and two horizontal lines at the bottom, resembling waves. The trademark symbol 'TM' is located in the upper right corner of the 'R' shape. The logo has a clean and modern design.
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Image /page/10/Picture/0 description: The image shows a logo with a blue square outline. Inside the square is a stylized letter 'R' also in blue. The 'R' is formed by a curved line at the top and two horizontal lines in the middle, giving it a modern and minimalist appearance. There is a 'TM' symbol in the upper right corner of the square, indicating a trademark.
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Image /page/11/Picture/0 description: The image shows a blue logo with a stylized letter 'R' inside a square. The 'R' is formed by a curved line at the top and two wavy lines at the bottom. The square is open on the right side. There is a 'TM' symbol in the upper right corner of the 'R'.
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Image /page/12/Picture/0 description: The image shows a blue logo with a stylized letter 'R' inside a square. The 'R' is formed by two curved lines, with the top line slightly shorter than the bottom line. The square is open on the right side, and the 'R' is positioned within the open space. The letters 'TM' are located in the upper right corner of the 'R'.
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Image /page/13/Picture/0 description: The image shows a logo with a blue square outline. Inside the square is a stylized letter 'R' formed by curved lines. The top part of the 'R' is a curved line, and the bottom part consists of two curved lines resembling waves. There is a 'TM' symbol in the upper right corner of the square.
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Image /page/14/Picture/0 description: The image shows a logo with a blue square outline. Inside the square is a stylized letter 'R' formed by curved lines. The top part of the 'R' is a curved line, and the bottom part consists of two parallel curved lines resembling waves. There is a 'TM' symbol in the upper right corner of the square.
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Image /page/15/Picture/0 description: The image shows a logo with a stylized letter 'R' inside a square frame. The 'R' is formed by a curved line with two horizontal lines extending from it, resembling waves. The logo is colored in a bright blue hue, and there is a 'TM' symbol in a smaller font size placed near the upper right corner of the 'R'.
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Image /page/16/Picture/0 description: The image shows a logo with a stylized letter 'R' inside a square. The 'R' is formed by a curved line at the top and two horizontal lines below, resembling a river. The square and the 'R' are both in a bright blue color. There is a small 'TM' symbol in the upper right corner of the square, indicating a trademark.
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Image /page/17/Picture/0 description: The image shows a blue logo with a stylized letter 'R' inside a square. The 'R' is formed by a curved line at the top and two wavy lines at the bottom. The square is open on the right side. There is a 'TM' symbol in the upper right corner of the 'R'.
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Image /page/18/Picture/0 description: The image shows a logo with a stylized letter 'R' inside a square. The 'R' is formed by a curved line at the top and two horizontal lines below, resembling a river. The square and the 'R' are both in a bright blue color. There is a small 'TM' symbol in the upper right corner of the square, indicating a trademark.
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Image /page/19/Picture/0 description: The image shows a logo with a blue square outline. Inside the square is a stylized letter 'R' formed by curved lines. The top part of the 'R' is a curved line, and the bottom part consists of two curved lines resembling waves. There is a 'TM' symbol in the upper right corner of the square.
510(k) Summary
7. PERFORMANCE TESTING
7.1.1. Performance Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The Rology Teleradiology Platform was considered a 'moderate level of concern'.
The performance testing (design verification and design validation) verified that the design requirements were successfully met.
Performance testing included the following tests and results:
| Performance Test | Result |
|---|---|
| User Interface/Input | Pass |
| Drag and Drop Import | Pass |
| Image Storage | Pass |
| Performance Test | Result |
| Textual Reports | Pass |
| Database software | Pass |
| Grayscale Image Rendering | Pass |
| RGB Image Rendering | Pass |
| Distance Markers | Pass |
| Study Data Overlays | Pass |
| Stack Navigation Tool | Pass |
| Window Level | Pass |
| Zoom in on the Image | Pass |
| Panning | Pass |
| Invert image | Pass |
| Text Annotation | Pass |
| MIP/MPR Reconstruction | Pass |
| Area Measurement Annotation | Pass |
| Angle Measurement Annotation | Pass |
| User Interface text styles, colors, fonts, and icons. | Pass |
| WebGL Rendering Optimizations | Pass |
| Support for high-resolution Retina displays | Pass |
| Keyboard shortcuts | Pass |
| Localizer Lines | Pass |
| Performance Test | Result |
| Localizer Point | Pass |
| Color Inversion | Pass |
| Orientation Markers | Pass |
| Clockwise/Counterclockwise Rotation | Pass |
| Search | Pass |
| Cobb Angle Measurement Annotation | Pass |
| Thumbnail viewing | Pass |
| Automatic Upload | Pass |
| Worklist | Pass |
| Download Report | Pass |
| Recheck | Pass |
| Pick up studies | Pass |
| Side-by-side Comparison | Pass |
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Image /page/20/Picture/0 description: The image shows a blue logo with a stylized letter 'R' inside a square. The 'R' is formed by a curved line and two horizontal lines, resembling waves. A small 'TM' symbol is located in the upper right corner of the square, indicating a trademark. The logo has a clean and modern design.
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Image /page/21/Picture/0 description: The image shows a blue logo with a stylized letter 'R' inside a square frame. The 'R' is formed by a curved line at the top and two wavy lines at the bottom, creating a modern and minimalist design. A small 'TM' symbol is placed to the right of the 'R', indicating a trademark.
510(k) Summary
The Intended use and user needs were successfully validated using appropriate validation partners representing the intended users of the Rology Teleradiology Platform.
As the intended use, functionality and performance of the Rology Teleradiology Platform and predicate device are equivalent, the result of the performance testing is evidence that the Rology Teleradiology Platform performs in an equivalent manner to the Braid device. Additional features which are not found in the predicate device, such as Cobb angle measurement and support of PET/US images, are common features for DICOM viewers under regulation 892.2050 and product code LLZ. These functionalities are supported by the inclusion of the BOX reference device in this submission.
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Image /page/22/Picture/0 description: The image shows a logo with a stylized letter 'R' inside a blue square. The 'R' is formed by a curved line that resembles a wave, and there's a small 'TM' symbol in the upper right corner of the square. The logo has a clean and modern design, using a single color for both the letter and the square.
510(k) Summary
7.1.2. Clinical Performance Testing
No clinical performance testing was performed for the Rology Teleradiology Platform in support of this submission.
8. CONCLUSION
The Rology Teleradiology Platform has the same intended use as the predicate Braid (K200822). The Rology Teleradiology Platform has equivalent technological characteristics and performance characteristics as compared to the Braid device. The BOX DICOM Viewer (K1519570 was included as a reference device to support the inclusion of the PET and Ultrasound (US) image modalities as well as the Cobb Angle measurement. These functions are not included in the Braid device. Based on device comparisons and the acceptable results of the performance testing, it is determined that the Rology Teleradiology Platform is substantially equivalent to its predicate device.
§ 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).