(47 days)
Not Found
No
The summary describes a standard DICOM viewer and storage system with no mention of AI or ML capabilities.
No
The device is a DICOM viewer for medical images, used for diagnosis and viewing, not for treating any condition or disease.
No
The device is a DICOM viewer for medical images and is explicitly stated as a "viewing tool for medical image studies," not a tool for diagnosis. The contraindication also specifies it's "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," indicating it aids those who diagnose but doesn't perform the diagnosis itself.
Yes
The device description explicitly states "The BOX DICOM Viewer™ is a software system" and details its functions as receiving, organizing, storing, and viewing DICOM images via software components and network communication. There is no mention of accompanying hardware provided by the manufacturer.
Based on the provided information, the BOX DICOM Viewer™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them... used by hospitals, imaging centers, radiologist reading practices." It is a viewing tool for medical images.
- Device Description: The description reinforces that it's a "software system to be used to view DICOM compliant studies" and a "viewing tool for medical image studies."
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The BOX DICOM Viewer™ does not perform any analysis on biological specimens. It processes and displays medical images acquired from imaging modalities like CT, MR, US, and PET, which are in vivo (within the body) imaging techniques.
The device is a medical image management and viewing system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The BOX DICOM Viewer™ is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal formation available across a network via web and customized user interfaces. The BOX DICOM Viewer™ is used by hospitals, imaging centers, radiologist reading practices.
Contraindications: The BOX DICOM Viewer™ 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The BOX DICOM Viewer™ is a software system to be used to view DICOM compliant studies, which are stored. The BOX DICOM Viewer™ is intended for professional use only as a viewing tool for medical image studies.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by hospitals, imaging centers, radiologist reading practices.
Qualified medical personnel only who are qualified to create and diagnose radiological image data.
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)
Nonclinical Testing:
The BOX DICOM Viewer™ system and configuration has been assessed and tested at BOX Inc. and has passed all pre-determined testing criteria. The Verification & Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by the BOX DICOM Viewer™ software in each operational mode and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated, that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by BOX Inc., integration and installations verification tests are conducted aqainst acceptance criteria prior to release to the client.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2015
BOX, Inc. % Mr. Carl Alletto Consultant OTech, Inc. 8317 Belew Drive MCKINNEY TX 75071
Re: K151957
Trade/Device Name: BOX DICOM Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 18, 2015 Received: August 25, 2015
Dear Mr. Alletto:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name BOX DICOM Viewer™
Indications for Use (Describe)
The BOX DICOM Viewer™ is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal formation available across a network via web and customized user interfaces. The BOX DICOM Viewer™ is used by hospitals, imaging centers, radiologist reading practices.
Contraindications: The BOX DICOM Viewer™ 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
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3
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
June 16, 2015
Submitter's Information: 21 CFR 807.92(a)(1)
Mr. Crispen Maung, VP Compliance BOX INc. 4440 El Camino Real Los Altos, CA 94022 USA Email: compliance@ box.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | BOX DICOM Viewer™ |
|---|---|
| Common Name: | Picture, archive and communications system |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiological23 |
|---|---|
| 510(k) Number | K132799 |
| Device Name | CLARISO PACS |
| Applicant | CLARISO, INC. |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 09/06/2013 |
| Decision Date | 11/07/2013 |
| Decision | substantially equivalent (SESE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| summary | summary |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
Device Description: 21 CFR 807 92(a)(4)
The BOX DICOM Viewer™ is a software system to be used to view DICOM compliant studies, which are stored. The BOX DICOM Viewer™ is intended for professional use only as a viewing tool for medical image studies.
4
510(k) Summary
BOX Inc. has acquired Clariso Inc. which included Clariso PACS (K132799), and cleared on November 11, 2013. The full features and functions of Clariso have been imported to the BOX DICOM Viewer, which includes the CLARISO PACS Viewer technology and features;
- Grayscale Image Rendering ●
- RGB Image Rendering ●
- Localizer Lines ●
- Localizer Point ●
- Orientation Markers
- Distance Markers
- Study Data Overlays
- Stack Navigation Tool
- Window/Level Tool
- Zoom Tool
- Panning Tool
- Horizontal/Vertical Flip
- Clockwise/Counterclockwise Rotation
- Color Inversion
- Text Annotation
- Area Measurement Annotation ●
- Angle Measurement Annotation
- Cobb Angle Measurement Annotation ●
In addition, the BOX Inc. has;
- Added new styles, colors, fonts, and icons were added for "BOX" look-and-feel
- Added WebGL rendering optimizations,
- . Added Hardware accelerated rendering
- Added support for high resolution Retina displays,
- . Added keyboard shortcuts for all tools and all annotation types
The BOX DICOM VIEWER software allows for acquisition of images from DICOM devices and lets users view those images from their personal computers. A third party DICOM device sends to the Box DICOM Proxy listener, the files are then sent to the Upload Proxy, then to the DICOM processor where the DICOM header data is extracted. Finally, the BOX DICOM VIEWER will communicate with a database component to store all the information required for patients, users, studies and configuration settings.
Indications for Use: 21 CFR 807 92(a)(5)
The BOX DICOM Viewer™ 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 web and customized user interfaces. The BOX DICOM Viewer™ is used by hospitals, imaging centers, radiologist reading practices.
Contraindications: The BOX DICOM Viewer™ 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.
5
Technological Characteristics: 21 CFR 807 92(a)(6)
The BOX DICOM Viewer™ is a software application that handles and manipulates digital medical images. The device does not contact the patient, nor does it control any life sustaining devices.
A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. In general, a PACS (Picture Archiving and Communication System) is a medical imaging technology which provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via the PACS; this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is DICOM 3.x (Digital Imaging and Communications in Medicine). Non-image data, such as scanned documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use.
The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. Both systems have been developed to replace traditional film handling in radiology. The 2 devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use. The predicate device and the new device are compared below:
The following information compares the predicate device and new device. Any differences between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
| Ref
| Functionality | Predicate:
CLARISO PACS
(K132799) | Subject Device:
BOX DICOM
Viewer | If different, Impact on
Safety and or Efficacy |
|----------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Web Browser
Software | Google Chrome
for all features.
Microsoft Internet
Explorer &
Mozilla Firefox for
features except
the
DICOM Viewer | Same as
predicate | No differences between
predicate and subject
device. |
| 2 | Intended use | Acquiring,
viewing, editing
and storing
radiographs and
related patients
images | Same as
predicate | No difference |
| 3 | Intended user | Radiologist &
qualified medical
personnel | Same as
predicate | No difference |
| 4 | Network | 10/100/100
Ethernet | Same as
predicate | No difference |
| Ref
| Functionality | Predicate:
CLARISO PACS
(K132799) | Subject Device:
BOX DICOM
Viewer | If different, Impact on
Safety and or Efficacy |
| 5 | Monitor | Above 19inch
monitor (Using
1280x1024) | Same as
predicate | No difference |
| 6 | User interaction/input | Same, Using
1280x1024 | Same as
predicate | No difference |
| 7 | Import / export
images | Yes | Same as
predicate | No difference |
| 8 | Acquisition devices | CT, MR, US, PET | Same as
predicate | No difference |
| 9 | Image organization | Patient ID, Name,
study instance
UID | Same as
predicate | No difference |
| 10 | Image search
available | Same | Same as
predicate | No difference |
| 11 | Image storage | Yes | Same as
predicate | No difference |
| 12 | Database software | MySQL | Same as
predicate | No difference |
| 13 | Greyscale Image
Rendering | Yes | Same as
predicate | No difference |
| 14 | RGB Image
Rendering | Yes | Same as
predicate | No difference |
| 15 | Localizer Lines | Yes | Same as
predicate | No difference |
| 16 | Localizer Point | Yes | Same as
predicate | No difference |
| 17 | Orientation Markers | Yes | Same as
predicate | No difference |
| 18 | Distance Markers | Yes | Same as
predicate | No difference |
| 19 | Study Data Overlays | Yes | Same as
predicate | No difference |
| 20 | Stack Navigation | Yes | Same as
predicate | No difference |
| 21 | Window Level | Yes | Same as
predicate | No difference |
| 22 | Zoom in on images | Yes | Same as
predicate | No difference |
| 23 | Panning | Yes | Same as
predicate | No difference |
| 24 | Horizontal/Vertical
Flip | Yes | Same as
predicate | No difference |
| 25 | Clockwise/Countercl
ockwise rotate | Yes | Same as
predicate | No difference |
| 26 | Invert image | Yes | Same as
predicate | No difference |
| Ref
| Functionality | Predicate:
CLARISO PACS
(K132799) | Subject Device:
BOX DICOM
Viewer | If different, Impact on
Safety and or Efficacy |
| 27 | Text Annotation | Yes | Same as
predicate | No difference |
| 28 | Area measurement
annotation | Yes | Same as
predicate | No difference |
| 29 | Angle measurement
annotation | Yes | Same as
predicate | No difference |
| 30 | Cobb Angle
Measurement
Annotation | Yes | Same as
predicate | No difference |
| 31 | Image annotation | Yes | Same as
predicate | No difference |
| 32 | Security | Yes | Same as
predicate | No difference |
| 33 | DICOM 3.0
conformance | Yes | Same as
predicate | No difference |
| 34 | Worklist | Yes | Same as
predicate | No difference |
| 35 | Thumbnail viewing | Yes, thumbnails
on preview,
small, medium
and large | Same as
predicate | No difference |
| 36 | Login | Yes | Same as
predicate | No difference |
| 37 | Audit | Yes, a tool to
view access logs
in real time. | Same as
predicate | No difference |
| 38 | User Interface text
styles, colors, fonts,
and icons. | CLARISO PACS
styles | BOX Styles | Yes, there are differences,
however these changes do
not affect device functions
and does not raise new
potential safety risks.
Therefore, it is our
determination that there is
"No impact on safety or
efficacy" |
| 39 | WebGL rendering
optimizations | No hardware
acceleration. | Yes, Hardware
acceleration is
used. | Yes, there are differences.
See item 39 in section
7.1.1.1 below. |
| 40 | Support for high
resolution Retina
displays | Pixelated display
on high-DPI
displays only
(i.e., "Retina
Displays"). | Full pixel density
on all displays | Yes, there is a difference.
The subject device will
display the full pixel density
of the saved image where
the predicate device only
did so if it was set to
"Retina Display" mode. This
difference actually aids the
viewer to always see the
image as captured by the
modality. The difference |
| Ref
| Functionality | Predicate:
CLARISO PACS
(K132799) | Subject Device:
BOX DICOM
Viewer | If different, Impact on
Safety and or Efficacy |
| | | | | does not affect the device
IFU and does not raise new
potential safety risks.
Therefore, it is our
determination that there is
"No impact on safety or
efficacy" |
| 41 | keyboard shortcuts
for all tools and all
annotation types | Limited keyboard
shortcut support. | Keyboard
shortcuts allowed
for tools and all
annotation types. | Yes, there is a difference.
In the predicate, it was not
possible for the User to use
the inherent functions of the
operating system to create
keyboard short cuts. In the
subject device, keyboard
shortcuts allowed for tools
and all annotation types
which may help the User
view images. |
6
7
8
DIFFERENCE FOR ITEM 39 EXPLAINED
| Ref
| Functionality | Impact on Safety and or Efficacy |
|----------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 39 | WebGL rendering
optimizations | 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. WebGL is
integrated completely into all the web standards of Internet browsers,
allowing GPU accelerated usage of physics and image processing
and effects as part of the web page canvas. WebGL elements can be
mixed with other HTML elements and composited with other parts of
the page or page background. WebGL programs consist of control
code written in JavaScript and shader code that is executed on a
computer's Graphics Processing Unit (GPU). Google Chrome -
WebGL has been enabled on all platforms that have a capable
graphics card with updated drivers since version 9, released in
February 2011. By default, Windows Chrome uses the ANGLE
(Almost Native Graphics Layer Engine) renderer to translate OpenGL
ES to Direct X 9.0c or 11.0, which have better driver support. On
Linux and Mac OS X the default renderer is OpenGL however, it is
also possible to force OpenGL as the renderer on Windows. In
computing, hardware acceleration is the use of computer hardware to
perform some functions faster than is possible in software running on
a more general-purpose CPU. Examples of hardware acceleration
include blitting acceleration functionality in graphics processing units
(GPUs) and regular expression hardware acceleration for spam
control in the server industry. Normally, processors are sequential,
and instructions are executed one by one. Various techniques are
used to improve performance; hardware acceleration is one of them.
The main difference between hardware and software is concurrency,
allowing hardware to be much faster than software. Hardware
accelerators are designed for computationally intensive software
code. Depending upon granularity, hardware acceleration can vary |
9
510(k) Summary
| Ref
| Functionality | Impact on Safety and or Efficacy |
|----------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | from a small functional unit to a large functional block (like motion
estimation in MPEG-2). The hardware that performs the acceleration,
when in a separate unit from the CPU, is referred to as a hardware
accelerator, or often more specifically as a 3D accelerator,
cryptographic accelerator, etc. Those terms, however, are older and
have been replaced with less descriptive terms like video card or
network adapter. |
| | | Yes, there are differences, between the predicate and the subject
device for WebGL since the subject device uses hardware
acceleration and the predicate does not. However this difference do
not affect the device IFU and does not raise new potential safety risks.
The device has been tested and has passed predetermined criteria
and therefore, it is our determination that there is "No impact on safety
or efficacy". |
Nonclinical Testing:
The BOX DICOM Viewer™ system and configuration has been assessed and tested at BOX Inc. and has passed all pre-determined testing criteria. The Verification & Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by the BOX DICOM Viewer™ software in each operational mode and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated, that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by BOX Inc., integration and installations verification tests are conducted aqainst acceptance criteria prior to release to the client.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for the BOX DICOM Viewer™ contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The modification to the subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
Therefore, the BOX DICOM Viewer™ is substantially equivalent to the predicate device.