(131 days)
No
The summary describes a teleradiology platform with standard image viewing and manipulation tools, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a teleradiology platform that receives, views, manipulates DICOM images, and provides textual reports for diagnostic purposes. It is a viewing and reporting tool, not a therapeutic device.
Yes
The Rology Teleradiology Platform is intended to be used by clinicians for interpretation/diagnosis of medical images, and its DICOM Viewer module explicitly allows users "to diagnose, manipulate, and interpret the studies."
Yes
The device is explicitly described as "Software as a Medical Device (SaMD) system" and its components are software modules for receiving, viewing, manipulating, organizing, and storing DICOM images and reports. While it interacts with hardware (DICOM devices, personal computers for viewing), the device itself is the software platform.
Based on the provided text, the Rology Teleradiology Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Rology's Function: The Rology Teleradiology Platform deals with medical images (DICOM images) acquired from imaging modalities like CR, DX, CT, MR, US, and PET. It provides tools for viewing, manipulating, organizing, and reporting on these images.
- No Specimen Analysis: The platform does not involve the analysis of biological specimens. Its input is image data, not biological samples.
The Rology Teleradiology Platform is clearly described as a Software as a Medical Device (SaMD) used for teleradiology purposes, which involves the remote interpretation of medical images. This falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis.
Product codes
LLZ
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.
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, DX, CT, MR, US, PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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)
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:
- 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
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.
No clinical performance testing was performed for the Rology Teleradiology Platform in support of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Phone | |
| Number | 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 |
| Common | |
| Name | Medical image management and processing system |
| Product Code | LLZ |
| Regulation | |
| Number | 892.2050 |
4
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
| Name | System, Image Processing, Radiological |
|---|---|
| Regulatory | |
| Class | Class 2 |
| Review Panel | Radiology |
| Indications | 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. |
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 |
5
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.
6
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:
7
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).
8
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:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957 | Comments |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Rology, Inc. | Braid.Health | BOX, Inc | N/A |
| Device Name | Rology
Teleradiology
Platform | Braid | BOX
DICOM
Viewer | N/A |
| Product Code | LLZ | LLZ | LLZ | Same |
| Regulation Number | 21 CFR 892.2050 | 21 CFR
892.2050 | 21 CFR
892.2050 | Same |
| Intended
Use/Indications for
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 | Braid is a
software
teleradiology
system used to
receive DICOM
images,
scheduling
information and
textual reports,
organize and
store them in an
internal format,
and to make that
information
available across
a network via | The BOX
DICOM
Viewer is
a software
Teleradiol
ogy
system
used to
receive
DICOM
images,
schedulin
g
informatio
n and
textual | The proposed
indications for
the Rology
Teleradiology
Platform are
equivalent to
Braid
predicate
device with
the exception
of support for
PET images
and Cobb
Angle
calculation.
Both of these |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957) | Comments |
| | 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/diag
nosis.
Contraindications:
Rology
Teleradiology
Platform is not
intended for the
acquisition of
mammographic
image data for
primary diagnosis. | web. Braid is
used by
hospitals, clinics,
imaging centers,
and radiologist
reading
practices. Braid
can optionally be
used for mobile
diagnostic use
for review and
analysis of CR,
DX, CT, and MR
images and
medical reports.
Braid mobile
diagnostic use is
not intended to
replace full
diagnostic
workstations and
should only be
used when there
is no access to a
workstation.
Braid mobile
diagnostic use is
not intended for
the display of
mammography
images for
diagnosis. When
images are | reports,
organize
and store
them in an
internal
format,
and to
make that
informatio
n
available
across a
network
via web
and
customize
d user
interfaces.
The BOX
DICOM
Viewer is
used by
hospitals,
imaging
centers,
radiologist
reading
practice.
Contraindi
cations:
The BOX
DICOM
Viewer is | functions are
present in the
BOX DICOM
Viewer
reference
device.
Additionally,
the Rology
Teleradiology
Platform has
the same
intended use
as both the
predicate and
reference
device. All
three devices
are intended
to be used to
receive
DICOM
images,
schedule
information
and textual
reports,
organize and
store them in
an internal
format, and to
make that
information
available |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957) | Comments |
| | | reviewed and use
as an element of
diagnosis, it is
the responsibility
of the trained
physician to
determine if the
image quality is
suitable for their
clinical
application.
Contraindication
s: Braid is not
intended for the
acquisition of
mammographic
image data and is
meant to be used
by qualified
medical
personnel only
who are qualified
to create and
diagnose
radiological
image data. | not
intended
for the
acquisitio
n of
mammogr
aphic
image
data and is
meant to
be used by
qualified
medical
personnel
only who
are
qualified
to create
and
diagnose
radiologic
al image
data. | across a
network via
web. |
| Intended user | Radiologists &
Qualified medical
personnel | Radiologists &
Qualified
medical
personnel | Radiologi
sts &
Qualified
medical
personnel | Same |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957) | Comments |
| Acquisition devices | CR, DX, CT, MR,
US, PET | CR, DX, CT,
MR | CT, MR,
US, PET | Rology
Teleradiology
Platform
supports PET
and US
images as
does the BOX
DICOM
Viewer
reference
device. |
| Communication | DICOM | DICOM | DICOM | Same |
| Network Access | Web browser | Web browser | Web
browser | Same |
| Web Browser
Software | Google Chrome | Google Chrome,
Safari | Google
Chrome
for all
features.
Microsoft
Internet
Explorer
& Mozilla
Firefox
for
features
except the
DICOM
Viewer. | Equivalent -
each product
supports the
Google
Chrome
internet
browser. |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957
) | Comments |
| Mobile Platforms | None | iPhones, iPads | None | The Rology
Teleradiology
Platform does
not support
mobile
platforms.
This is
equivalent to
the reference
device. The
lack of
support for
mobile
platforms
does not add
different
questions
related to
safety or
effectiveness. |
| User Interface/Input | Mouse and
keyboard | Mouse keyboard,
and
Touchscreens | Mouse
and
keyboard | Equivalent
input type.
The Rology
Teleradiology
Platform does
not support
touchscreen
use. This is
equivalent to
the reference
device. The
lack of |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957) | Comments |
| | | | | support for
touchscreen
use does not
add different
questions
related to
safety or
effectiveness. |
| Drag and Drop Import | No | Yes | Yes | The subject
device does
not have this
feature, but
the absence of
this feature
does not raise
questions of
safety and
effectiveness
or affect the
intended use
of the device. |
| Image Storage | Yes | Yes | Yes | Same |
| Textual Reports | Yes | Yes | No | Same as the
predicate
device |
| Database software | MongoDB | CouchDB,
IndexedDB,
LevelDB | MySQL | MongoDB is
an alternative
to CouchDB,
IndexedDB,
LevelDB, and |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957) | Comments |
| | | | | MySQL
database
software,
which can
provide the
same
functionalities |
| Grayscale Image
Rendering | Yes | Yes | Yes | Same |
| RGB Image
Rendering | No | No | Yes | Same as the
predicate
device |
| 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:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957
) | Comments |
| MIP/MPR
Reconstruction | Yes | Yes | No | Same as the
predicate
device |
| Area Measurement
Annotation | Yes | Yes | Yes | Same |
| Angle Measurement
Annotation | Yes | Yes | Yes | Same |
| User Interface text
styles, colors, fonts,
and icons. | None | None | BOX
Styles | Same as the
predicate
device |
| WebGL Rendering
Optimizations | Yes | Yes | Yes | Hardware
acceleration is
used. WebGL
(Web
Graphics
Library) is a
JavaScript
API for
rendering
interactive 3D
computer
graphics and
2D graphics
within any
compatible
web browser
without the
use of plug-ins. |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957) | Comments |
| | | | | of this
technology
raises no new
questions of
safety and
effectiveness
and is
supported by
performance
testing. |
| Support for high-
resolution Retina
displays | Full pixel density
on all displays | Full pixel density
on all displays | Full pixel
density on
all
displays | 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/Counterclo
ckwise Rotation | Yes | Unknown | Yes | Equivalent to
the reference
device |
| Search | Yes | Unknown | Yes | Equivalent to
the reference
device |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957) | Comments |
| Cobb Angle
Measurement
Annotation | Yes | Unknown | Yes | Equivalent to
the reference
device |
| Thumbnail viewing | Yes | Unknown | Yes | Equivalent to
the reference
device |
| Automatic Upload | Yes | No | No | The addition
of this feature
raises no new
questions of
safety and
effectiveness
and is
supported by
performance
testing |
| Worklist | Yes | Unknown | Yes | Equivalent to
the reference
device |
| Download Report | Yes | Unknown | Unknown | The addition
of this feature
raises no new
questions of
safety and
effectiveness
and is
supported by
performance
testing |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957
) | Comments |
| Recheck | Yes | No | No | The addition
of this feature
raises no new
questions of
safety and
effectiveness
and is
supported by
performance
testing |
| Pick up studies | Yes | No | No | The addition
of this feature
raises no new
questions of
safety and
effectiveness
and is
supported by
performance
testing |
| Side-by-side
Comparison | Yes | Unknown | Unknown | The addition
of this feature
raises no new
questions of
safety and
effectiveness
and is
supported by
performance
testing |
| Feature/Function | Subject Device:
Rology
Teleradiology
Platform | Predicate
Device: Braid
(K200822) | Reference
Device:
BOX
DICOM
Viewer
(K151957) | Comments |
| Play | Yes | Unknown | Unknown | The addition
of this feature
raises no new
questions of
safety and
effectiveness
and is
supported by
performance
testing. |
9
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.
10
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.
11
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'.
12
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'.
13
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.
14
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.
15
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'.
16
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.
17
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'.
18
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.
19
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 |
20
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.
21
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.
22
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.