Who is the manufacturer of BOX DICOM Viewer?

Box, Inc. filed the 510(k) submission for BOX DICOM Viewer (K151957).

What is the FDA product code for BOX DICOM Viewer?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for BOX DICOM Viewer?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like BOX DICOM Viewer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BOX DICOM Viewer

K151957 · Box, Inc. · LLZ · Sep 1, 2015 · Radiology

Device Facts

Record ID	K151957
Device Name	BOX DICOM Viewer
Applicant	Box, Inc.
Product Code	LLZ · Radiology
Decision Date	Sep 1, 2015
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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.

Device Story

BOX DICOM Viewer is a teleradiology software system for viewing DICOM-compliant medical images. Input: DICOM images, scheduling info, and reports received from third-party DICOM devices via a proxy listener. Processing: DICOM header extraction, database storage, and web-based rendering. Output: Visual display of medical images with tools for grayscale/RGB rendering, measurements (distance, area, angle, Cobb angle), annotations, and image manipulation (zoom, pan, flip, rotate). Used in hospitals, imaging centers, and reading practices by radiologists and qualified medical personnel. The system utilizes WebGL and hardware-accelerated rendering for performance. Healthcare providers use the viewer to interpret radiological data, facilitating clinical decision-making by providing convenient, network-accessible image access, replacing traditional film handling.

Clinical Evidence

Bench testing only. Verification and validation testing were conducted to evaluate input/output functions and software performance across all operational modes. Results demonstrated that the device met all predetermined acceptance criteria.

Technological Characteristics

Software-based teleradiology system; DICOM 3.x compliant; utilizes MySQL database; web-based interface (Chrome, IE, Firefox); WebGL API for 2D/3D graphics; hardware-accelerated rendering; supports high-resolution Retina displays; network connectivity via 10/100/100 Ethernet.

Indications for Use

Indicated for use by qualified medical personnel to receive, organize, store, and view DICOM images, scheduling information, and textual reports. Not intended for acquisition of mammographic image data.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

CLARISO PACS (K132799)

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Submission Summary (Full Text)

{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) K151957 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 "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}------------------------------------------------ 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.