Who is the manufacturer of Multi Modality Viewer?

Vital Images, Inc. filed the 510(k) submission for Multi Modality Viewer (K161419).

What is the FDA product code for Multi Modality 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 Multi Modality Viewer?

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

Who can help prepare an FDA 510(k) submission like Multi Modality 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.

Multi Modality Viewer

K161419 · Vital Images, Inc. · LLZ · Jul 13, 2016 · Radiology

Device Facts

Record ID	K161419
Device Name	Multi Modality Viewer
Applicant	Vital Images, Inc.
Product Code	LLZ · Radiology
Decision Date	Jul 13, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Multi Modality Viewer is a software application within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.

Device Story

Multi Modality Viewer is a software application operating on the Vitrea platform; it processes DICOM-compliant medical images from MRI and CT scanners. The device provides tools for image navigation, manipulation, and analysis, including 2D/MPR/4D viewing, MIP/MinIP, image subtraction, semi-automated stitching, and measurement tools (distance, angle, Cobb angle, ROIs). It enables side-by-side comparison of multiple series and studies. Used in clinical settings by radiologists, clinicians, or technologists, the software assists in reviewing images to support efficient patient care. Output is displayed on a workstation for clinical decision-making. The device benefits patients by facilitating accurate, efficient diagnostic review and comparison of radiological data.

Clinical Evidence

No clinical studies were required. Safety and effectiveness were supported by bench testing, including software verification (performance and safety testing) and validation (simulated usability testing by experienced professionals).

Technological Characteristics

Software-based radiological image processing application. Operates on the Vitrea platform. Supports DICOM standards (PS 3.1-3.20). Implements standard image manipulation algorithms (MIP/MinIP, registration, subtraction). Complies with ISO 14971 (risk management) and IEC 62304 (software lifecycle).

Indications for Use

Indicated for clinicians, radiologists, or technologists to examine and manipulate medical images from MRI and CT scanners for patient care. No specific patient population, disease, or condition limitations apply.

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

MR Core Software (K151115)

Reference Devices

Softread Software (Vitrea® 2, Version 3.5 Medical Image Processing Software) (K040305)

Related Devices

K163574 — Multi Modality Viewer · Vital Images, Inc. · Jan 26, 2017
K182230 — Multi Modality Viewer · Vital Images, Inc. · Sep 7, 2018
K151115 — MR Core Software · Vital Images, Inc. · Jun 3, 2015
K201477 — syngo.via View&GO · Siemens Healthcare GmbH · Jul 1, 2020
K040305 — VITREA2 VERSION 3.5 · Vital Images, Inc. · Feb 24, 2004

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 stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is positioned inside a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 13, 2016 Vital Images, Inc. % Ms. Katie Ryan Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414 Re: K161419 Trade/Device Name: Multi Modalitv Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 20, 2016 Received: May 23, 2016 Dear Ms. Ryan: 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}------------------------------------------------ Page 2-Ms. Katie Ryan 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, Michael D. Hara Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health For Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K161419 Device Name Multi Modality Viewer Indications for Use (Describe) Multi Modality Viewer is a software application within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> × </div> | |----------------------------------------------|-------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> | #### 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}------------------------------------------------ # 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 Multi Modality Viewer software which is substantially equivalent to the FDA cleared MR Core Software (K151115). | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN, 55343-4414 | | Establishment Registration: | 2134213 | | Contact Person: | Katie Ryan, M.S. Regulatory Affairs Specialist Phone : 952-487-9793 Fax: 952-487-9510 E-mail: kryan@vitalimages.com | | 510(k) Type: | Traditional | | Summary Date: | May 20, 2016 | | Device Trade Name: | Multi Modality Viewer | | Device Common Name/ Regulatory Description: | Radiological Image Processing Software, 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 | ## Predicate Device(s): | Predicate Device | Manufacturer | FDA 510(k) Number | |------------------|--------------------|-------------------| | MR Core Software | Vital Images, Inc. | K151115 | {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. The letters are bold and sans-serif. The background is white. ## Reference Device(s): | Reference Device | Manufacturer | FDA 510(k) Number | |---------------------------------------------------------------------------------------|--------------------|-------------------| | Softread Software (Vitrea® 2, Version 3.5 Medical Image Processing Software) | Vital Images, Inc. | K040305 | ## Device Description: Multi Modality Viewer is a software application which functions on the Vitrea Platform, cleared by K150258. This application allows intuitive navigation, and manipulation of medical images obtained from MRI and CT scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data. lt provides clinical tools to review images to help qualified physicians provide efficient and effective patient care. #### Key features: General Viewing: - · Linked 2D, MPR and 4D viewers for single and multi-study comparison - · Creation of retrievable evidence and snapshots - · User defined flexible display protocols Access to Advanced Applications and Workflows: - In application access to MR Stitching application - · Evidence creation and sharing across workflows General Image Display, Manipulation, and Analysis Tools: - · Maximum and Minimum Intensity Projection (MIP/MinIP) - · Identification and Display of Regions of Interest (ROIs) - · CINE image display - · Multi-frame display - · Color image display - . Simultaneous multiple studies review - · Cross-reference lines support - Display of selected images, series, or entire study . - · Comparison of multiple series or studies - · Scroll - Pan - Zoom - · Focus - · Flip (Vertically, horizontally) - Invert - · Rotate (Clockwise, counter-clockwise) - · Arrow {5}------------------------------------------------ - · Adjust Registration - · Auto window level/width setting - · Text/Arrow annotation (Label) - · Measurement of distance (Ruler), Angle, Cobb Angle, Ellipse ROI, and Freehand ROI Specialized Tools: - · Image subtraction of two series/datasets - · Access to semi-automated image stitching - Study and series linking . - · Register two different series or groups that do not share a frame of reference to link them spatially ## Intended Use / Indications for Use: Multi Modality Viewer is a software application within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data. ## Intended for Disease / Condition / Patient Population: Multi Modality Viewer is medical image viewer software. Therefore, particular information of intended for disease, condition, and patient population is not applicable. # Substantial Equivalence Comparison: ## Regulatory Comparison: | | Subject Device | Predicate Device | | |----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Multi Modality Viewer | MR Core Software (K151115) | Comparison | | Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological | 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 | Under Review | June 3, 2015 | Predicate device is cleared | | | Subject Device | Predicate Device | Comparison | | Criteria | Multi Modality Viewer | MR Core Software (K151115) | Comparison | | Indications for Use | Multi Modality Viewer is a software application within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data. | MR Core is an option within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI scanners. The option also enables clinicians to compare multiple series for the same patient, side-by- side, and switch to other integrated applications to further exam the data. | Similar Added support for the ability to examine and manipulate medical images obtained from CT scanners was not part of the predicate device's indications for use. | | Intended Users | Radiologists, Clinicians or Technologists | Radiologists, Clinicians or Technologists | Same | | Patient Population | Multi Modality Viewer is medical image viewer software. Therefore, particular information of intended for disease, condition, and patient population is not applicable. | MR Core Software is medical image viewer software. Therefore, particular information of intended for disease, condition, and patient population is not applicable. | Same | | Modality Support | CT and MRI | MRI | Similar Added support for the ability to examine and manipulate medical images obtained from CT scanners was not part of the predicate device's indications for use. | | | Subject Device | Predicate Device | | | Criteria | Multi Modality Viewer | MR Core Software (K151115) | Comparison | | Data Loading | | | | | Image Communication Standard: DICOM | Yes | Yes | Same | | Data Viewing Support | | | | | 2D Image Review | Yes | Yes | Same | | 2D Comparative Review | Yes | Yes | Same | | Features and Capabilities | | | | | Multi-Planner Reformatting | Yes | Yes | Same | | Maximum and Minimum Intensity Projection (MIP/MinIP) | Yes | Yes | Same | | Image Editing, Setting, Saving | Yes | Yes | Same | | Annotation & Tagging Tools (Label) | Yes | Yes | Same | | Display Options (e.g. thickness) | Yes | Yes | Same | | Quantitative Measurements | Yes | Yes | Same | | Snapshot | Yes | Yes | Same | | Cine Image Display | Yes | Yes | Same | | Multi-frame Display | Yes | Yes | Same | | Color Image Display | Yes | Yes | Same | | Criteria | Subject Device | Predicate Device | | | | Multi Modality Viewer | MR Core Software (K151115) | Comparison | | Simultaneous Multiple Studies Review | Yes | Yes | Same | | Cross-reference Lines Support | Yes | Yes | Same | | Display of Selected Images, Series, or Entire Study | Yes | Yes | Same | | Comparison of Multiple Series or Studies | Yes | Yes | Same | | Scroll Image | Yes | Yes | Same | | Zoom Image | Yes | Yes | Same | | Pan Image | Yes | Yes | Same | | Focus Image | Yes | Yes | Same | | Rotate Image | Yes | Yes | Same | | Flip Image - Vertical | Yes | Yes | Same | | Flip Image - Horizontal | Yes | Yes | Same | | Rotate Image - Clockwise | Yes | Yes | Same | | Rotate Image - Counter-clockwise | Yes | Yes | Same | | Invert Image | Yes | Yes | Same | | Arrow | Yes | Yes | Same | | Auto Window Level/Width Setting | Yes | Yes | Same | | Measurement of Distance | Yes | Yes | Same | | Measurement of Angle | Yes | Yes | Same | | Criteria | Subject Device Multi Modality Viewer | Predicate Device MR Core Software (K151115) | Comparison | | Measurement of Cobb Angle | Yes | Yes | Same | | Identification and Display of Ellipse Regions of Interest (ROIs) | Yes | Yes | Same | | Identification and Display of Freehand Regions of Interest (ROIs) | Yes | Yes | Same | | Manual Registration | Yes | Yes | Same | | Image subtraction of two series/datasets | Yes | Yes | Same | | Study and Series Linking | Yes | Yes | Same | | Semi-automated image stitching | Yes | Yes | Same | | Time Intensity Analysis | Yes | Yes | Same | | Batch Save of MPR reformats | Yes | Yes | Same | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are bold and sans-serif. The background is white. ## Indications for Use Comparison with Predicate Device: {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "VITAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered. ## Similarities in Technology with Predicate Device: {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are all capitalized and evenly spaced. Page: 010-6 (of 13) {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced. The background is white. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced. The image is simple and clean, with a focus on the word itself. | | Subject Device | Predicate Device | | |------------------------------------------|-----------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…