Rology Teleradiology Platform (v.1.22.1103)

K231385 · Rology, Inc. · LLZ · Sep 20, 2023 · Radiology

Device Facts

• Record ID: K231385
• Device Name: Rology Teleradiology Platform (v.1.22.1103)
• Applicant: Rology, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

Web-based teleradiology software system; receives, views, manipulates, schedules, stores, and reports DICOM images. Operates via cloud-based infrastructure (AWS S3); integrates with medical systems using DICOM and HL7/FHIR protocols. Used by radiologists and qualified medical professionals in clinical settings. Input: DICOM-compliant studies from imaging devices. Processing: Rology Connect module handles acquisition, anonymization, compression, and cloud upload; Workflow Manager organizes studies; DICOM Viewer enables image manipulation (MIP/MPR, measurements, window/level, etc.) and reporting. Output: Visualized images and textual reports for clinical review. Assists clinicians in diagnostic interpretation; radiologist retains ultimate responsibility for final diagnosis.

Clinical Evidence

No clinical performance testing was performed. Evidence consists of bench testing, including software verification and validation, confirming that all design requirements and functional features (imaging tools, reporting, connectivity) were successfully met.

Technological Characteristics

Web-based SaMD; cloud-hosted (AWS S3). Connectivity via DICOM, HL7, and FHIR. Features include grayscale rendering, MIP/MPR reconstruction, and measurement tools (distance, area, angle, Cobb angle). Software utilizes WebGL for hardware-accelerated rendering. Compatible with standard web browsers (Google Chrome).

Indications for Use

Indicated for use by qualified clinicians (radiologists, technologists, medical professionals) in hospitals, clinics, and imaging centers to aid in reading, interpreting, and reporting radiological images. Supports CR, DX, CT, MR, US, and PET modalities. Contraindicated for the acquisition of mammographic image data for primary diagnosis.

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

• Braid (K200822)

Reference Devices

• BOX DICOM Viewer (K151957)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span> <svg height="15" width="15"> <rect fill="lightgray" height="15" stroke="black" width="15"></rect> <line stroke="black" x1="0" x2="15" y1="0" y2="15"></line> <line stroke="black" x1="0" x2="15" y1="15" y2="0"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" width="15"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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,<br>United States of America |
| Phone Number | 302 561 9511 |
| Fax Number | N/A |
| Company Representative | Amr Abodraiaa |
| Email | [e-mail] |
| Primary Contact | Jim Luker |
| Primary Contact Phone<br>Number | 321 205 3104 |
| Primary Contact Email | [e-mail] |
| Date Summary Prepared | September 15, 2023 |

#### 2. SUBJECT DEVICE INFORMATION

| Trade Name | Rology Teleradiology Platform |
|----------------------|------------------------------------------------|
| 510(k) # | K231385 |
| Common<br>Name | Medical image management and processing system |
| Product Code | LLZ |
| Regulation<br>Number | 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

| Classification<br>Name | System, Image Processing, Radiological |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory<br>Class | Class 2 |
| Review Panel | Radiology |
| Indications | The Rology Teleradiology Platform is a Web-based software system used to<br>receive, view and manipulate DICOM images, schedule, provide textual<br>reports, organize, store, and make such information available.<br><br>When images are reviewed and used as an element of diagnosis, it is the<br>responsibility of the qualified clinician to determine if the image quality is<br>suitable for their clinical application.<br><br>The Rology Teleradiology Platform is intended to be used by clinicians<br>qualified in the use of radiological images for interpretation/diagnosis.<br><br>Contraindications: Rology Teleradiology Platform is not intended for the<br>acquisition 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:<br>Rology<br>Teleradiology<br>Platform | Predicate<br>Device: Braid<br>(K200822) | Reference<br>Device:<br>BOX<br>DICOM<br>Viewer<br>(K151957 | Comments |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Rology, Inc. | Braid.Health | BOX, Inc | N/A |
| Device Name | Rology<br>Teleradiology<br>Platform | Braid | BOX<br>DICOM<br>Viewer | N/A |
| Product Code | LLZ | LLZ | LLZ | Same |
| Regulation Number | 21 CFR 892.2050 | 21 CFR<br>892.2050 | 21 CFR<br>892.2050 | Same |
| Intended<br>Use/Indications for<br>Use | The Rology<br>Teleradiology<br>Platform is a Web-<br>based software<br>system used to<br>receive, view and<br>manipulate<br>DICOM images,<br>schedule, provide<br>textual reports,<br>organize, store,<br>and make such<br>information<br>available.<br>When images are<br>reviewed and used | Braid is a<br>software<br>teleradiology<br>system used to<br>receive DICOM<br>images,<br>scheduling<br>information and<br>textual reports,<br>organize and<br>store them in an<br>internal format,<br>and to make that<br>information<br>available across<br>a network via | The BOX<br>DICOM<br>Viewer is<br>a software<br>Teleradiol<br>ogy<br>system<br>used to<br>receive<br>DICOM<br>images,<br>schedulin<br>g<br>informatio<br>n and<br>textual | The proposed<br>indications for<br>the Rology<br>Teleradiology<br>Platform are<br>equivalent to<br>Braid<br>predicate<br>device with<br>the exception<br>of support for<br>PET images<br>and Cobb<br>Angle<br>calculation.<br>Both of these |
| Feature/Function | Subject Device:<br>Rology<br>Teleradiology<br>Platform | Predicate<br>Device: Braid<br>(K200822) | Reference<br>Device:<br>BOX<br>DICOM<br>Viewer<br>(K151957) | Comments |
| | as an element of<br>diagnosis, it is the<br>responsibility of<br>the qualified<br>clinician to<br>determine if the<br>image quality is<br>suitable for their<br>clinical<br>application.<br>The Rology<br>Teleradiology<br>Platform is<br>intended to be<br>used by clinicians<br>qualified in the use<br>of radiological<br>images for<br>interpretation/diag<br>nosis.<br>Contraindications:<br>Rology<br>Teleradiology<br>Platform is not<br>intended for the<br>acquisition of<br>mammographic<br>image data for<br>primary diagnosis. | web. Braid is<br>used by<br>hospitals, clinics,<br>imaging centers,<br>and radiologist<br>reading<br>practices. Braid<br>can optionally be<br>used for mobile<br>diagnostic use<br>for review and<br>analysis of CR,<br>DX, CT, and MR<br>images and<br>medical reports.<br>Braid mobile<br>diagnostic use is<br>not intended to<br>replace full<br>diagnostic<br>workstations and<br>should only be<br>used when there<br>is no access to a<br>workstation.<br>Braid mobile<br>diagnostic use is<br>not intended for<br>the display of<br>mammography<br>images for<br>diagnosis. When<br>images are | reports,<br>organize<br>and store<br>them in an<br>internal<br>format,<br>and to<br>make that<br>informatio<br>n<br>available<br>across a<br>network<br>via web<br>and<br>customize<br>d user<br>interfaces.<br>The BOX<br>DICOM<br>Viewer is<br>used by<br>hospitals,<br>imaging<br>centers,<br>radiologist<br>reading<br>practice.<br>Contraindi<br>cations:<br>The BOX<br>DICOM<br>Viewer is | functions are<br>present in the<br>BOX DICOM<br>Viewer<br>reference<br>device.<br>Additionally,<br>the Rology<br>Teleradiology<br>Platform has<br>the same<br>intended use<br>as both the<br>predicate and<br>reference<br>device. All<br>three devices<br>are intended<br>to be used to<br>receive<br>DICOM<br>images,<br>schedule<br>information<br>and textual<br>reports,<br>organize and<br>store them in<br>an internal<br>format, and to<br>make that<br>information<br>available |
| Feature/Function | Subject Device:<br>Rology<br>Teleradiology<br>Platform | Predicate<br>Device: Braid<br>(K200822) | Reference<br>Device:<br>BOX<br>DICOM<br>Viewer<br>(K151957) | Comments |
| | | reviewed and use<br>as an element of<br>diagnosis, it is<br>the responsibility<br>of the trained<br>physician to<br>determine if the<br>image quality is<br>suitable for their<br>clinical<br>application.<br>Contraindication<br>s: Braid is not<br>intended for the<br>acquisition of<br>mammographic<br>image data and is<br>meant to be used<br>by qualified<br>medical<br>personnel only<br>who are qualified<br>to create and<br>diagnose<br>radiological<br>image data. | not<br>intended<br>for the<br>acquisitio<br>n of<br>mammogr<br>aphic<br>image<br>data and is<br>meant to<br>be used by<br>qualified<br>medical<br>personnel<br>only who<br>are<br>qualified<br>to create<br>and<br>diagnose<br>radiologic<br>al image<br>data. | across a<br>network via<br>web. |
| Intended user | Radiologists &<br>Qualified medical<br>personnel | Radiologists &<br>Qualified<br>medical<br>personnel | Radiologi<br>sts &<br>Qualified<br>medical<br>personnel | Same |
| Feature/Function | Subject Device:<br>Rology<br>Teleradiology<br>Platform | Predicate<br>Device: Braid<br>(K200822) | Reference<br>Device:<br>BOX<br>DICOM<br>Viewer<br>(K151957) | Comments |
| Acquisition devices | CR, DX, CT, MR,<br>US, PET | CR, DX, CT,<br>MR | CT, MR,<br>US, PET | Rology<br>Teleradiology<br>Platform<br>supports PET<br>and US<br>images as<br>does the BOX<br>DICOM<br>Viewer<br>reference<br>device. |
| Communication | DICOM | DICOM | DICOM | Same |
| Network Access | Web browser | Web browser | Web<br>browser | Same |
| Web Browser<br>Software | Google Chrome | Google Chrome,<br>Safari | Google<br>Chrome<br>for all<br>features.<br>Microsoft<br>Internet<br>Explorer<br>& Mozilla<br>Firefox<br>for<br>features<br>except the<br>DICOM<br>Viewer. | Equivalent -<br>each product<br>supports the<br>Google<br>Chrome<br>internet<br>browser. |
| Feature/Function | Subject Device:<br>Rology<br>Teleradiology<br>Platform | Predicate<br>Device: Braid<br>(K200822) | Reference<br>Device:<br>BOX<br>DICOM<br>Viewer<br>(K151957<br>) | Comments |
| Mobile Platforms | None | iPhones, iPads | None | The Rology<br>Teleradiology<br>Platform does<br>not support<br>mobile<br>platforms.<br>This is<br>equivalent to<br>the reference<br>device. The<br>lack of<br>support for<br>mobile<br>platforms<br>does not add<br>different<br>questions<br>related to<br>safety or<br>effectiveness. |
| User Interface/Input | Mouse and<br>keyboard | Mouse keyboard,<br>and<br>Touchscreens | Mouse<br>and<br>keyboard | Equivalent<br>input type.<br>The Rology<br>Teleradiology<br>Platform does<br>not support<br>touchscreen<br>use. This is<br>equivalent to<br>the reference<br>device. The<br>lack of |
| Feature/Function | Subject Device:<br>Rology<br>Teleradiology<br>Platform | Predicate<br>Device: Braid<br>(K200822) | Reference<br>Device:<br>BOX<br>DICOM<br>Viewer<br>(K151957) | Comments |
| | | | | support for<br>touchscreen<br>use does not<br>add different<br>questions<br>related to<br>safety or<br>effectiveness. |
| Drag and Drop Import | No | Yes | Yes | The subject<br>device does<br>not have this<br>feature, but<br>the absence of<br>this feature<br>does not raise<br>questions of<br>safety and<br>effectiveness<br>or affect the<br>intended use<br>of the device. |
| Image Storage | Yes | Yes | Yes | Same |
| Textual Reports | Yes | Yes | No | Same as the<br>predicate<br>device |
| Database software | MongoDB | CouchDB,<br>IndexedDB,<br>LevelDB | MySQL | MongoDB is<br>an alternative<br>to CouchDB,<br>IndexedDB,<br>LevelDB, and |
| Feature/Function | Subject Device:<br>Rology<br>Teleradiology<br>Platform | Predicate<br>Device: Braid<br>(K200822) | Reference<br>Device:<br>BOX<br>DICOM<br>Viewer<br>(K151957) | Comments |
| | | | | MySQL<br>database<br>software,<br>which can<br>provide the<br>same<br>functionalities |
| Grayscale Image<br>Rendering | Yes | Yes…