Who is the manufacturer of VitreaView?

Vital Images, Inc. filed the 510(k) submission for VitreaView (K150738).

What is the FDA product code for VitreaView?

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

What is the regulatory pathway for VitreaView?

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

What are the predicate devices for VitreaView?

VitreaView (K122136); ViTALConnect (K071362).

Who can help prepare an FDA 510(k) submission like VitreaView?

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.

VitreaView

K150738 · Vital Images, Inc. · LLZ · Apr 6, 2015 · Radiology

Device Facts

Record ID	K150738
Device Name	VitreaView
Applicant	Vital Images, Inc.
Product Code	LLZ · Radiology
Decision Date	Apr 6, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

Device Story

VitreaView is a cross-browser, zero-footprint universal medical image viewer; enables clinicians to access multi-modality DICOM/non-DICOM images, reports, and patient data from disparate archives. Operates via web browser without client-side installation; integrates with EHR, EMR, HIE, and PHR systems. Supports diagnostic-quality review, multi-dimensional visualization, and treatment planning. Features include markup tools, comparative review, volume rendering, and cine playback. Used by physicians and clinicians in clinical environments; mobile access restricted to informational use. Healthcare providers use the viewer to access images in context with patient records, facilitating collaboration and clinical decision-making. Benefits include improved access to imaging data and streamlined diagnostic workflows.

Clinical Evidence

No clinical studies were required. Evidence consists of bench testing, software verification (performance and safety), and validation (simulated usability testing). External validation by radiologists confirmed diagnostic quality of images based on brightness, sharpness, and artifact assessment.

Technological Characteristics

Zero-footprint, web-based software; HTML/JavaScript. Supports DICOM/non-DICOM data. Features: MPR, 3D volume rendering, annotation, measurement, and linking. Connectivity: Networked/Cloud-integrated. Security: HTTPS/SSL encryption, LDAP/Active Directory authentication. Standards: DICOM (PS 3.1-3.20), ISO 14971:2007 (Risk Management), IEC 62304:2006 (Software Life Cycle).

Indications for Use

Indicated for medical image viewing and information distribution for diagnosis, review, communication, and reporting of multi-modality DICOM and non-DICOM data. Not for primary interpretation of lossy compressed mammography or digitized film screen images. Mobile access is for informational purposes only, not diagnostic use.

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

VitreaView (K122136)
ViTALConnect (K071362)

Related Devices

K111892 — VITREAVIEW SOFTWARE 6.1 · Vital Images, Inc. · Jul 28, 2011
K163232 — Vitrea View · Vital Images, Inc. · Jul 21, 2017
K122136 — VITREAVIEW · Vital Images, Inc. · Sep 7, 2012
K223048 — Medisystem Pacs · Medilab Manutencao E Sitemas Ltda · Jun 23, 2023
K200546 — ZeeroMED View · O3 Enterprise Srl · May 5, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 6, 2015 Vital Images, Inc. % Mr Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414 Re: K150738 Trade/Device Name: VitreaView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 18, 2015 Received: March 20, 2015 Dear Mr. Shah: 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. Acting 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) K150738 Device Name VitreaView # Indications for Use (Describe) VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other pation. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. 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 Druq 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 the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is a slightly lighter shade. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. # 510(k) Summary This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c) | Basis for the Submission: | Modifications to a legally marketed device which are not qualified for a Special 510(k) notification | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Vital Images, Inc. 5850 Opus Parkway Suite 300 Minnetonka, MN, 55343-4414 | | Establishment Registration: | 2134213 | | Contact Person: | Parthiv Shah Sr. Regulatory Affairs Specialist Phone : 952-487-9574 Fax: 952-487-9510 E-mail: pshah@vitalimages.com | | 510(k) Type: | Traditional | | Summary Date: | March 30, 2015 | | Device Trade Name: | VitreaView Software | | Device Common Name / Regulatory Description: | Picture Archiving and Communications System | | Device Classification Name: | System, Image Processing, Radiological | | Regulation Number: | 21 CFR 892.2050 | | Product Code: | LLZ | | Regulatory Classification: | Class II | | Device Panel: | Radiology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "VITAL" in black font. Underneath the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The font of the word "VITAL" is sans-serif. The dot above the "i" in "VITAL" is a circle. # Predicate Devices: | Predicate Device(s) | Manufacturer | FDA 510(k) number | |---------------------|--------------------|-------------------| | VitreaView | Vital Images, Inc. | K122136 | | ViTALConnect | Vital Images, Inc. | K071362 | # Device Description: VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning. VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to install client systems, due to the zero footprint/zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. # Intended Use / Indications for Use: VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. When accessing VitreaView from a mobile device, imaqes viewed are for informational purposes only and not intended for diagnostic use. # Intended for Disease / Condition / Patient Population: VitreaView is medical image viewer software. Therefore, particular information of intended for disease, condition, and patient population is not applicable. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "VITAL" in black, with a red tagline underneath that says "A Toshiba Medical Systems Group Company". The word "VITAL" is written in a bold, sans-serif font, with a dot above the "i". The tagline is written in a smaller, serif font. # Software Changes (from the last 510(k) clearance K122136): # Key changes: - Query on demand searches archives in real-time directly from the source without the need for an index - Color and Greyscale Softcopy Presentation State (CSPS and GSPS) ● - Easy study navigation and study sharing via email, including bookmarking ● - View DICOM key image objects that have been saved with a study - . Comparative review allows users to view multiple studies and to track and quantify changes - . Markup tools allow you to create measurements and add annotations, with indication if off-screen - . Window/Level sets specific window-level, grayscale-inverted, a user preset or stored-DICOM - Volume rendering presets allow you to change the appearance of the 3D view - Enhanced notifications for study changes and study processing . - Linking is available across modalities and can be applied to duplicated series. A default ● set of linking options are remembered by modality and applied to linked series, including: navigation, window/level and zoom per modality. - . Auto-Cine enables users of cine to quickly see the dynamic view of studies most often viewed in cine mode - Provides diagnostic quality image review to medical professionals . # Other minor enhancements: - Annotation Indicator ● - Markup Scrollbar Indicator for easy access to key slices . - Bookmarks automatically save when users log out ● - Query retrieve progress indicator - Text annotation is available with the Arrow tool ● - Arrow tool is available from the Ruler toolbar ● - Ability to review the report and move through the VitreaView studies ● - Calibration handling for projection modalities ● - . Windows 8.1 support - Internet Explorer 11 support ● - Windows 8 support ● - Internet Explorer 10 support ● - Administrators can remove changed or deleted studies from the VitreaView Study List by ● authorized permissions - . The updated URL encryption method provides additional security for patient health information (PHI) - Support for automatic LDAP group mapping ● - . Structured reports can be created from metadata during the initial study load - The patient demographics display within the viewport has been refined to show more ● information when the browser is resized - . Custom actions are available to define specific search behavior - Improved selection of the viewport layout - MINT storage can be optimized to minimize overhead - Improved access to related images and documents ● - . The status of Pending has been added to Administration Change Sets - Ability to redirect the user to another URL . {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image. - Ability to use a custom logout hook ● - . Carousel swipe navigation - . Ability to disable pixel measurements - . Ability to disable logout # Substantial Equivalence Comparison: #### . Regulatory Comparison | Characteristic | Modified VitreaView Software (Submission Subject) | 510(k) Cleared VitreaView Software (K122136) (Predicate Device-1) | ViTALConnect (K071362) (Predicate Device-2) | Noted Differences | |------------------------|---------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------|--------------------------------| | Classification Name | Picture Archiving and Communications System | Picture Archiving and Communications System | Picture Archiving and Communications System | None | | Regulatory Number | 892.2050 | 892.2050 | 892.2050 | None | | Product Code | LLZ | LLZ | LLZ | None | | Classification | Class II | Class II | Class II | None | | Review Panel | Radiology | Radiology | Radiology | None | | Decision Date | Under Review | September 7, 2012 | May 30, 2007 | Both predicates are cleared | #### Intended Use / Indications for Use Comparison with the Predicate Device-1 . | Characteristic | Modified VitreaView Software (Submission Subject) | 510(k) Cleared VitreaView Software (K122136) (Predicate Device-1) | Noted Differences | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / Indications for Use | VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi- modality softcopy | VitreaView is a medical image viewing and information distribution application that provides access, through the Internet and within the enterprise, to multi- modality softcopy | The only changes in the Intended Use statements are as below: • The following line from the Intended Use statement of already cleared VitreaView | | Characteristic | Modified VitreaView Software (Submission Subject) | 510(k) Cleared VitreaView Software (K122136) (Predicate Device-1) | Noted Differences | | medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. | medical images, reports and other patient- related information, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis. When accessed from a mobile tablet, VitreaView is for informational purposes only and not intended for diagnostic use. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. | 510(k) — K122136 has been removed: "VitreaView is not intended for primary diagnosis" The following word has been added the in the updated Intended Use statement: "for diagnosis" | | | Modality Support | Multi-modality | Multi-modality | None | | Characteristic | Modified VitreaView Software (Submission Subject) | VITALConnect (K071362) (Predicate Device-2) | Noted Differences | | Intended Use / Indications for Use | VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi- modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. | VITALConnect, Version 4.1 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. VITALConnect is not meant for primary Image Interpretation In mammography. | None Both software products provide diagnostic quality medical image review for multi-dimensional digital images acquired from a variety of imaging devices. | | Characteristic | Modified VitreaView Software (Submission Subject) | ViTALConnect (K071362) (Predicate Device-2) | Noted Differences | | Modality Support | Multi-modality | Multi-modality | None | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a circle. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot above the "i" in "VITAL" is a perfect circle. #### Intended Use / Indications for Use Comparison with the Predicate Device-2 ● {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a perfect circle. #### Device Description Comparison with the Predicate Device-1 • | Characteristic | Modified VitreaView Software (Submission Subject) | 510(k) Cleared VitreaView Software (K122136) (Predicate Device-1) | Noted Differences | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description | VitreaView is a cross- browser, cross- platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non- DICOM medical images for diagnosis, review, communication, and reporting. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing | VitreaView is a cross- browser, cross- platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non- DICOM medical images. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning. | The only change in the Device Description statements is as below: ● The support for diagnostic quality medical image review has been added into the subject device. | | Characteristic | Modified VitreaView Software (Submission Subject) | 510(k) Cleared VitreaView Software (K122136) (Predicate Device-1) | Noted Differences | | | and treatment planning. VitreaView offers medical professionals a universal viewer for accessing multi- dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero footprint/zero- download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. | VitreaView offers medical professionals a universal viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero footprint, zero- download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. When accessed the VitreaView software from a mobile device, the image viewed on the VitreaView software is for informational purposes only and not intended for diagnostic use. | | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "VITAL" in black font. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The letters in the word "VITAL" are all capitalized except for the "i", which is lowercase and has a dot above it. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. | Characteristic | Modified VitreaView Software (Submission Subject) | VITALConnect (K071362) (Predicate Device-2) | Noted Differences | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description | VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning. VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration | The VITALConnect system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The VITALConnect system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The VITALConnect system user interface follows typical clinical workflow patterns to process, review, and analyze digital images. | None Both software products provide diagnostic quality medical image review for multi-dimensional digital images acquired from a variety of imaging devices. | | Characteristic | Modified VitreaView Software (Submission Subject) | VITALConnect (K071362) (Predicate Device-2) | Noted Differences | | | and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero footprint/ zero- download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. | | | | | When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. | | | #### . Device Description Comparison with the Predicate Device-2 {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context. #### Technological Characteristics Similarity with the Predicate Device-1 ● | Modified VitreaView Software (Submission Subject) Technological Characteristic | Description | 510(k) Cleared VitreaView Software (K122136) (Predicate Device-1) | Explanation of Differences | |---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------| | Annotation and Measurement Tools | Line Angle Ruler Arrow | Same | Same | | User Installation Requirements | Runs within browser using HTML and JavaScript only No installation is required on user's machine | Same | Same | | Data Type Supported | DICOM Non-DICOM | Same | Same | | Image View/ Manipulation | Image Zoom Pan Window Level Auto Window Level Reset Scout Lines Image Rotate Image Flip Magnify Image Invert Image Cine | Same | Same | | Data Encryption | HTTPS SSL | Same | Same | | Patient Demographic Display | Capable of displaying patient demographic information | Same | Same | | Linking | Co-planar linking: Autolink Manual | Same | Same | | Modified VitreaView Software (Submission Subject) Technological Characteristic | Description | 510(k) Cleared VitreaView Software (K122136) (Predicate Device-1) | Explanation of Differences | | User and Password Control | Users can be managed via an internal database, active directory, or parent application | Same | Same | | Data Security | Stored on server | Same | Same | | Audit Trail | Audit trail logged | Same | Same | | User Management | Database structure allows mapping users to groups internally or mapping external groups (AD, parent application) to internal groups and role | Same | Same | | Transmission Modes | Via the web with Internet browsers | Same | Same | | File Type Used | • JPEG for Lossy data • PNG for Lossless data | Same | Same | | MPR Viewing | This viewing feature enables the display of reformatted CT and MR images into axial, coronal and sagittal orientations. | Same | Same | | 3D Volume Rendered Viewing | This viewing feature enables the display of 3D perspective views of CT and MR image sets that have been transformed into volumes. It also provides presets to enable users to alter the visualization | Same | Same | | Modified VitreaView Software (Submission Subject) Technological Characteristic | Description | 510(k) Cleared VitreaView Software (K122136) (Predicate Device-1) | Explanation of Differences | | | parameters of the 3D views to highlight features. | | | | Active Target Tool | This viewing feature provides a facility to view a single target location within multiple images. | Same | Same | | Crosshair Navigation and Synchronization: | This viewing feature provides a facility to synchronize and scroll through multiple views at the same time. | Same | Same | | Ability to clone images side by side | Ability to clone images side by side. | Same | Same | | Ability to close an image by clicking an "X" in the upper-left portion of the viewport | Ability to close an image by clicking an "X" in the upper-left portion of the viewport. | Same | Same | | Ability to select locale and language settings on the login screen | Ability to select locale and language settings on the login screen. | Same | Same | | Ability to customize the columns in the study directory by selecting the dropdown arrow on the right side of each column. | Ability to customize the columns in the study directory by selecting the dropdown arrow on the right side of each column. | Same | Same | | Help Tips | Proactive help tips appear for 10-15 seconds to educate users on certain functionality that may | Same | Same | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The text appears to be a company logo. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context. | Modified VitreaView Software (Submission Subject) Technological Characteristic | Description | 510(k) Cleared VitreaView Software (K122136) (Predicate Device-1) | Explanation of Differences | |-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------| | | not be obvious to a new user. | | | | Support for TIF Files | VitreaView can display TIF files. | Same | Same | | Tablet support for information purpose only (Not for diagnostic use) | This viewing feature provides access of VitreaView software on various iOS and Android tablet devices through the default internet browser. Key features are: Two-finger pinch to zoom and pan Touch and drag to scroll Double-tap to access Gesture menu Tap Carousel thumbnail, then tap Image Pane to…