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.

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BOX DICOM Viewer, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on a comparative approach, demonstrating substantial equivalence to a predicate device (CLARISO PACS, K132799). The performance is reported by stating that the subject device (BOX DICOM Viewer) matches or improves upon the predicate's functionalities without introducing new safety risks.

Functionality	Predicate (CLARISO PACS) Performance	Subject Device (BOX DICOM Viewer) Performance	Impact on Safety and/or Efficacy (if different)
Core Functionalities (1-37): Web Browser, Intended Use, Intended User, Network, Monitor, User Interaction/Input, Import/Export Images, Acquisition Devices, Image Organization, Image Search, Image Storage, Database Software, Greyscale Image Rendering, RGB Image Rendering, Localizer Lines, Localizer Point, Orientation Markers, Distance Markers, Study Data Overlays, Stack Navigation, Window Level, Zoom, Panning, Horizontal/Vertical Flip, Clockwise/Counterclockwise Rotate, Invert Image, Text Annotation, Area Measurement Annotation, Angle Measurement Annotation, Cobb Angle Measurement Annotation, Image Annotation, Security, DICOM 3.0 Conformance, Worklist, Thumbnail Viewing, Login, Audit	All "Yes" or specific descriptions (e.g., Google Chrome for browsers, 10/100/100 Ethernet, Above 19inch monitor, MySQL database)	"Same as predicate" for all these functionalities. The document states "The full features and functions of Clariso have been imported to the BOX DICOM Viewer".	"No differences between predicate and subject device" or "No difference". "No impact on safety or efficacy" for all these.
User Interface (38): Text styles, colors, fonts, and icons	CLARISO PACS styles	BOX Styles (new styles, colors, fonts, and icons were added)	"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'."
WebGL Rendering Optimizations (39): Hardware acceleration	No hardware acceleration.	Yes, Hardware acceleration is used. "WebGL rendering optimizations" are added.	"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'."
Support for high resolution Retina displays (40)	Pixelated display on high-DPI displays only (i.e., "Retina Displays").	Full pixel density on all displays. "Added support for high resolution Retina 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 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'."
Keyboard shortcuts for all tools and all annotation types (41)	Limited keyboard shortcut support.	Keyboard shortcuts allowed for tools and all annotation types. "Added keyboard shortcuts for all 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."

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of image data or patient cases for performance evaluation. The testing described is nonclinical testing related to the system's functionalities.

Sample Size for Test Set: Not applicable or not specified in terms of clinical cases/images. The testing appears to be functional verification and validation of the software itself.
Data Provenance: Not specified, as clinical data is not mentioned as part of the validation testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. As the validation is focused on technical functionalities and equivalence to a predicate, there is no mention of establishing ground truth by medical experts for image interpretation.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a DICOM viewer, not an AI-powered diagnostic tool, and the focus of the submission is on substantial equivalence to an existing viewer, not on improving human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence. The testing described as "Nonclinical Testing" and the "Verification & Validation Test Plan" appears to be a standalone evaluation of the software's functionalities against predetermined criteria. The document states: "The BOX DICOM Viewer™ system and configuration has been assessed and tested at BOX Inc. and has passed all pre-determined testing criteria." and "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."

However, it's crucial to note that this "standalone" performance refers to the functional capabilities of the viewer (e.g., rendering correctly, performing measurements, handling DICOM data), not a diagnostic algorithm's accuracy in identifying medical conditions. The device is explicitly described as a "viewing tool" for medical image studies and emphasizes that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

7. The type of ground truth used

The concept of "ground truth" in the clinical diagnostic sense (e.g., pathology, outcomes data) is not applicable to the nonclinical testing described for this device. The ground truth for this device's validation is based on:

Functional Specifications: The software's ability to perform its stated functions (e.g., display images, perform measurements, store data) as defined in its design.
Predicate Device Equivalence: The functions of the BOX DICOM Viewer are compared directly against the known and accepted functionalities of the CLARISO PACS predicate device.

8. The sample size for the training set

This information is not provided. The BOX DICOM Viewer is described as a software system that imports features from a previously cleared device and adds new functionalities. There is no mention of a "training set" in the context of machine learning or AI algorithm development, as the viewer itself is not presented as an AI diagnostic tool.

9. How the ground truth for the training set was established

This information is not provided, as there is no mention of a training set for an AI algorithm.

Summary

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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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

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Indications for Use

510(k) Number (if known)

K151957

Device Name BOX DICOM Viewer™

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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)

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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

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.

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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 DICOMViewer	If different, Impact onSafety and or Efficacy
1	Web BrowserSoftware	Google Chromefor all features.Microsoft InternetExplorer &Mozilla Firefox forfeatures excepttheDICOM Viewer	Same aspredicate	No differences betweenpredicate and subjectdevice.
2	Intended use	Acquiring,viewing, editingand storingradiographs andrelated patientsimages	Same aspredicate	No difference
3	Intended user	Radiologist &qualified medicalpersonnel	Same aspredicate	No difference
4	Network	10/100/100Ethernet	Same aspredicate	No difference
Ref#	Functionality	Predicate:CLARISO PACS(K132799)	Subject Device:BOX DICOMViewer	If different, Impact onSafety and or Efficacy
5	Monitor	Above 19inchmonitor (Using1280x1024)	Same aspredicate	No difference
6	User interaction/input	Same, Using1280x1024	Same aspredicate	No difference
7	Import / exportimages	Yes	Same aspredicate	No difference
8	Acquisition devices	CT, MR, US, PET	Same aspredicate	No difference
9	Image organization	Patient ID, Name,study instanceUID	Same aspredicate	No difference
10	Image searchavailable	Same	Same aspredicate	No difference
11	Image storage	Yes	Same aspredicate	No difference
12	Database software	MySQL	Same aspredicate	No difference
13	Greyscale ImageRendering	Yes	Same aspredicate	No difference
14	RGB ImageRendering	Yes	Same aspredicate	No difference
15	Localizer Lines	Yes	Same aspredicate	No difference
16	Localizer Point	Yes	Same aspredicate	No difference
17	Orientation Markers	Yes	Same aspredicate	No difference
18	Distance Markers	Yes	Same aspredicate	No difference
19	Study Data Overlays	Yes	Same aspredicate	No difference
20	Stack Navigation	Yes	Same aspredicate	No difference
21	Window Level	Yes	Same aspredicate	No difference
22	Zoom in on images	Yes	Same aspredicate	No difference
23	Panning	Yes	Same aspredicate	No difference
24	Horizontal/VerticalFlip	Yes	Same aspredicate	No difference
25	Clockwise/Counterclockwise rotate	Yes	Same aspredicate	No difference
26	Invert image	Yes	Same aspredicate	No difference
Ref#	Functionality	Predicate:CLARISO PACS(K132799)	Subject Device:BOX DICOMViewer	If different, Impact onSafety and or Efficacy
27	Text Annotation	Yes	Same aspredicate	No difference
28	Area measurementannotation	Yes	Same aspredicate	No difference
29	Angle measurementannotation	Yes	Same aspredicate	No difference
30	Cobb AngleMeasurementAnnotation	Yes	Same aspredicate	No difference
31	Image annotation	Yes	Same aspredicate	No difference
32	Security	Yes	Same aspredicate	No difference
33	DICOM 3.0conformance	Yes	Same aspredicate	No difference
34	Worklist	Yes	Same aspredicate	No difference
35	Thumbnail viewing	Yes, thumbnailson preview,small, mediumand large	Same aspredicate	No difference
36	Login	Yes	Same aspredicate	No difference
37	Audit	Yes, a tool toview access logsin real time.	Same aspredicate	No difference
38	User Interface textstyles, colors, fonts,and icons.	CLARISO PACSstyles	BOX Styles	Yes, there are differences,however these changes donot affect device functionsand does not raise newpotential safety risks.Therefore, it is ourdetermination that there is"No impact on safety orefficacy"
39	WebGL renderingoptimizations	No hardwareacceleration.	Yes, Hardwareacceleration isused.	Yes, there are differences.See item 39 in section7.1.1.1 below.
40	Support for highresolution Retinadisplays	Pixelated displayon high-DPIdisplays only(i.e., "RetinaDisplays").	Full pixel densityon all displays	Yes, there is a difference.The subject device willdisplay the full pixel densityof the saved image wherethe predicate device onlydid so if it was set to"Retina Display" mode. Thisdifference actually aids theviewer to always see theimage as captured by themodality. The difference
Ref#	Functionality	Predicate:CLARISO PACS(K132799)	Subject Device:BOX DICOMViewer	If different, Impact onSafety and or Efficacy
				does not affect the deviceIFU and does not raise newpotential safety risks.Therefore, it is ourdetermination that there is"No impact on safety orefficacy"
41	keyboard shortcutsfor all tools and allannotation types	Limited keyboardshortcut support.	Keyboardshortcuts allowedfor tools and allannotation types.	Yes, there is a difference.In the predicate, it was notpossible for the User to usethe inherent functions of theoperating system to createkeyboard short cuts. In thesubject device, keyboardshortcuts allowed for toolsand all annotation typeswhich may help the Userview images.

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DIFFERENCE FOR ITEM 39 EXPLAINED

Ref#	Functionality	Impact on Safety and or Efficacy
39	WebGL renderingoptimizations	WebGL (Web Graphics Library) is a JavaScript API for renderinginteractive 3D computer graphics and 2D graphics within anycompatible web browser without the use of plug-ins. WebGL isintegrated completely into all the web standards of Internet browsers,allowing GPU accelerated usage of physics and image processingand effects as part of the web page canvas. WebGL elements can bemixed with other HTML elements and composited with other parts ofthe page or page background. WebGL programs consist of controlcode written in JavaScript and shader code that is executed on acomputer's Graphics Processing Unit (GPU). Google Chrome -WebGL has been enabled on all platforms that have a capablegraphics card with updated drivers since version 9, released inFebruary 2011. By default, Windows Chrome uses the ANGLE(Almost Native Graphics Layer Engine) renderer to translate OpenGLES to Direct X 9.0c or 11.0, which have better driver support. OnLinux and Mac OS X the default renderer is OpenGL however, it isalso possible to force OpenGL as the renderer on Windows. Incomputing, hardware acceleration is the use of computer hardware toperform some functions faster than is possible in software running ona more general-purpose CPU. Examples of hardware accelerationinclude blitting acceleration functionality in graphics processing units(GPUs) and regular expression hardware acceleration for spamcontrol in the server industry. Normally, processors are sequential,and instructions are executed one by one. Various techniques areused 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. Hardwareaccelerators are designed for computationally intensive softwarecode. Depending upon granularity, hardware acceleration can vary

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510(k) Summary

Ref#	Functionality	Impact on Safety and or Efficacy
		from a small functional unit to a large functional block (like motionestimation in MPEG-2). The hardware that performs the acceleration,when in a separate unit from the CPU, is referred to as a hardwareaccelerator, or often more specifically as a 3D accelerator,cryptographic accelerator, etc. Those terms, however, are older andhave been replaced with less descriptive terms like video card ornetwork adapter.
		Yes, there are differences, between the predicate and the subjectdevice for WebGL since the subject device uses hardwareacceleration and the predicate does not. However this difference donot affect the device IFU and does not raise new potential safety risks.The device has been tested and has passed predetermined criteriaand therefore, it is our determination that there is "No impact on safetyor 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.

Regulation Number and Section

§ 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).

Indications for Use

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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FOR FDA USE ONLY

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Date Prepared:

Submitter's Information: 21 CFR 807.92(a)(1)

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Predicate Device: 21 CFR 807. 92(a)(3)

Device Description: 21 CFR 807 92(a)(4)

510(k) Summary

Indications for Use: 21 CFR 807 92(a)(5)

Technological Characteristics: 21 CFR 807 92(a)(6)

DIFFERENCE FOR ITEM 39 EXPLAINED

510(k) Summary

Nonclinical Testing:

Conclusion: 21 CFR 807 92(b)(1)

§ 892.2050 Medical image management and processing system.

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