Who is the manufacturer of Vitrea View?

Vital Images, Inc. filed the 510(k) submission for Vitrea View (K163232).

What is the FDA product code for Vitrea View?

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

What is the regulatory pathway for Vitrea View?

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

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

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.

Vitrea View

K163232 · Vital Images, Inc. · LLZ · Jul 21, 2017 · Radiology

Device Facts

Record ID	K163232
Device Name	Vitrea View
Applicant	Vital Images, Inc.
Product Code	LLZ · Radiology
Decision Date	Jul 21, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Vitrea View software is a medical image viewing and information application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), 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. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used. 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. Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists. When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

Device Story

Vitrea View is a web-based, zero-footprint enterprise image viewer. It aggregates DICOM and non-DICOM medical images and reports from disparate archives (PACS, VNA) for access via standard internet browsers on PCs, Macs, and mobile devices. It supports multi-modality viewing, including mammography and digital breast tomosynthesis. Clinicians use the software for diagnostic review, collaboration, and treatment planning. Key features include 2D/3D/MPR viewing, measurement tools, and contextual EHR/EMR integration. The device facilitates clinical decision-making by providing diagnostic-quality image access at the point of care. It benefits patients by enabling rapid, enterprise-wide access to imaging data, fostering collaboration among specialists, and supporting efficient diagnostic workflows.

Clinical Evidence

No clinical studies required. Bench testing included multi-reader, multi-case validation studies comparing Vitrea View to cleared reference systems (McKesson Radiology K140909 and Phillips Intellispace K111804). Four radiologists evaluated 50 mammography studies and three radiologists evaluated 50 digital breast tomosynthesis studies. Metrics included visualization of tissue, contrast, sharpness, and artifacts. Results confirmed clinical equivalence for diagnostic quality.

Technological Characteristics

Web-based, zero-footprint software architecture using HTML and JavaScript. Supports DICOM and non-DICOM data. Connectivity via HTTPS/SSL. Compatible with standard internet browsers on Windows, Mac, iOS, and Android. Complies with DICOM (PS 3.1-3.20), ISO 14971:2007 (risk management), and IEC 62304:2006 (software lifecycle).

Indications for Use

Indicated for qualified healthcare professionals (radiologists, non-radiology specialists, physicians, technologists) to access, view, and report on multi-modality medical images (including mammography and digital breast tomosynthesis) and patient data for diagnosis and review. 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 (K150738)

Reference Devices

McKesson Radiology (K140909)
Phillips Intellispace Radiology system (K111804)

Related Devices

K150738 — VitreaView · Vital Images, Inc. · Apr 6, 2015
K111892 — VITREAVIEW SOFTWARE 6.1 · Vital Images, Inc. · Jul 28, 2011
K122136 — VITREAVIEW · Vital Images, Inc. · Sep 7, 2012
K223048 — Medisystem Pacs · Medilab Manutencao E Sitemas Ltda · Jun 23, 2023
K221065 — MediLab · Sigma Scientific Services, LLC · Jun 10, 2022

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 21, 2017 Vital Images, Inc. % Fei Li Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343 Re: K163232 Trade/Device Name: Vitrea View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 14, 2017 Received: June 15, 2017 Dear Fei Li: 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. 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 {1}------------------------------------------------ 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, Michael D.'Hara For 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) K163232 Device Name Vitrea View #### Indications for Use (Describe) Vitrea View software is a medical image viewing and information distribution that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), 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. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used. 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. Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to. radiologists, non-radiology specialists, physicians and technologists. When accessing Vitrea View software 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) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "ViTAL" in all caps. The letters are black, except for the dot on the "i", which is red. The font is sans-serif and the letters are evenly spaced. # 510K 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: | Vital Images, Inc. hereby submits this traditional 510(k) to obtain 510(k) clearance for the Vitrea View software which we believe is substantially equivalent to the FDA cleared VitreaView (K150738). | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN, 55343-4414 | | Establishment Registration: | 2134213 | | Contact Person: | Fei Li Regulatory Affairs Specialist Phone : 952-487-9539 Fax: 952-487-9510 E-mail: fli@vitalimages.com Alternate Contact Person: Vince Swenson Sr. Director of Quality and Regulatory Phone: 952-487-9548 Fax: 952-487-9510 E-mail: vswenson@vitalimages.com | | 510(k) Type: | Traditional | | Summary Date: | November 16, 2016 | | Device Trade Name: | Vitrea View | | 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 letters. The "i" in "VITAL" has a red dot above it, resembling a candle flame. The font is sans-serif and the letters are evenly spaced. ## Predicate Device(s): | Predicate Device | Manufacturer | FDA 510(k) Number | |------------------|-------------------------------------------------------------------------------------------|-------------------| | VitreaView | Vital Images, Inc. 5850 Opus Parkway, Suite 300, Minnetonka, Minnesota 55343 U.S.A. | K150738 | #### Reference Device(s): | Reference Device | Manufacturer | FDA 510(k) Number | |-------------------------------------------|-----------------------------------------------------------------------------------------|-------------------| | McKesson Radiology | McKesson Medical Imaging Company 5995 Winward Parkway Alpharetta, GA 30005 | K140909 | | Phillips Intellispace Radiology system | Philips Healthcare Informatics, Inc. 4100 E 3rd Ave Ste 101 Foster City, CA 94404 | K111804 | ## Device Description: The Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and non-DICOM medical images. The Vitrea View software 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. The Vitrea View software is a communication tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care. The Vitrea View software offers medical professionals an enterprise 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 install client systems, due to the web-based zero-footbrint nature of the Vitrea View software. The Virea View software offers scalability to add new users as demand grows, and may be deployed in a virtualized environment. Some of the general features include: . Fast time-to-first-image - Contextual launch integration with single-sign-on ● - . Easy study navigation and search capability - Supports multi-modality vendor-neutral DICOM images - . Supports non-DICOM images - lmages display at full diagnostic quality (with appropriate hardware) ● - . Basic 2D review tools (zoom, pan, measure) - Basic 3D and MPR viewing ● - Radiology key images - . Comparative side-by-side review, regardless of image types - . Collaboration tools - . Leverages traditional DICOM as well as next-generation DICOMweb image transfer protocols - Enables federated access to across multiple data sources across multiple sites ● - . Web-based zero-footprint architecture - Secure Access on various Windows® and Mac computers through standard internet ● browsers - . Secure Access on various iOS®, Android™, and Windows® tablet devices through the device's Internet browser {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it, resembling a flame. The font is simple and sans-serif, and the letters are evenly spaced. - . Secure Access on various iOS and Android smartphones through the device's Internet browser #### Intended Use / Indications for Use: Vitrea View software is a medical image viewing and information application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), 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. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable requlatory approvals and quality control requirements for their use and maintenance. Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists. When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. #### Intended for Disease / Condition / Patient Population: Vitrea View software is a medical image viewer software. Therefore, specific information on the intended disease, condition, and patient population is not applicable. #### Key Changes from the last 510(k) clearance K150738 Kev Changes include: - Support for diagnostic viewing of mammographic images and digital breast tomography ● images - . Enhancements in the administration and support of the product - Ability to allow clinicians to collaborate on images, information, and artifacts related to the ● imaging studies using the Vitrea View software - User Centric enhancements - Performance Improvements - Licensing enhancements - Better integration with EMRs by supporting more targeted searchers within the launch and history search APIs - . Ability to record information of users who accessed the Vitrea View software and which studies they viewed - . Add support for Breast Tomography SOP class - . Support for SQL Server 2014 - Improvements in connectivity to archives including PACS, VNA and DICOMWeb . - . View the UDI for Vitrea View identification {6}------------------------------------------------ # ViTAL # Substantial Equivalence Comparison: # Regulatory Comparison: | Characteristic | Subject Device | Predicate Device | | |---------------------|------------------------------------------------------|------------------------------------------------------|--------------------------------| | | Vitrea View | VitreaView (K150738) | Comparison | | Classification Name | Picture Archiving and Communications System | Picture Archiving and Communications System | Same | | Regulatory Number | 892.2050 | 892.2050 | Same | | Product Code | LLZ | LLZ | Same | | Classification | Class II | Class II | Same | | Review Panel | Radiology | Radiology | Same | | Decision Date | TBD | April 6, 2015 | Predicate device is cleared | ### Indications for Use Comparison with Predicate Device: | | Subject Device | Predicate Device | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Criteria | Vitrea View | VitreaView (K150738) | Comparison | | | Indications for Use | Vitrea View software 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 (including mammography and digital breast tomosynthesis), 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. | 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 | Similar Added support for Vitrea View to be used for diagnostic viewing of mammographic images and digital breast tomography images | | | | Lossy compressed mammography | | | | | Criteria | Subject Device | Predicate Device | Comparison | | | | Vitrea View | VitreaView (K150738) | | | | | images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used. 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. Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non- radiology specialists, physicians and technologists. When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use. | 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. | | | | Intended Users | Qualified healthcare professionals including, but not restricted to, | Qualified healthcare professionals including, but not restricted to, | Same | | | Criteria | Subject Device | Predicate Device | Comparison | | | | Vitrea View | Vitrea View (K150738) | | | | | radiologists, non- radiology specialists, physicians and technologists. | radiologists, non- radiology specialists, physicians and technologists. | | | | Patient Population | Vitrea View software is a medical image viewer software. Therefore, specific information on the intended disease, condition, and patient population is not applicable. | VitreaView is a medical image viewer software. Therefore, specific information on the intended disease, condition, and patient population is not applicable. | Same | | | Modality Support | Multi-modality | Multi-modality | Same | | | Criteria | Description | Subject Device Vitrea View | Predicate Device VitreaView (K150738) | Comparison | | Annotation and Measurement Tools | • Line • Angle • Ruler • Arrow | Yes | Yes | Same | | User Installation Requirements | • Runs within browser using HTML and JavaScript only • No installation is required on user's machine | Yes | Yes | Same | | Data Type Supported | • DICOM • Non-DICOM | Yes | Yes | Same | | Image View/ Manipulation | • Image Zoom • Pan • Window Level • Auto Window Level • Reset • Scout Lines • Image Rotate • Image Flip • Magnify • Image Invert • Image Cine | Yes | Yes | Same | | Data Encryption | • HTTPS • SSL | Yes | Yes | Same | | Patient Demographic Display | Capable of displaying patient demographic information | Yes | Yes | Same | | Linking | Co-planar linking: • Autolink • Manual | Yes | Yes | Same | | User and Password Control | Users can be managed via an internal database, active directory, or parent application | Yes | Yes | Same | | Data Security Audit Trail | Stored on server Audit trail logged | Yes Yes | Yes Yes | Same Same | | Criteria | Description | Subject Device Vitrea View | Predicate Device Vitrea View (K150738) | Comparison | | User Management | Database structure allows mapping users to groups internally or mapping external groups (AD, parent application) to internal groups and role | Yes | Yes | Same | | Transmission Modes | Via the web with Internet browsers | Yes | Yes…