Who is the manufacturer of VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)?

Vital Images, Inc. filed the 510(k) submission for VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) (K141302).

What is the FDA product code for VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)?

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 CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)?

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

What are the predicate devices for VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)?

Vitrea 2, version 3.7 Medical Image Processing Software - Cardiac Functional Analysis (K043333); CardIQ Function Xpress (K073153).

Who can help prepare an FDA 510(k) submission like VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)?

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 CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)

K141302 · Vital Images, Inc. · LLZ · Aug 1, 2014 · Radiology

Device Facts

Record ID	K141302
Device Name	VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
Applicant	Vital Images, Inc.
Product Code	LLZ · Radiology
Decision Date	Aug 1, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, right ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.

Device Story

The Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) is a post-processing software application for the Vitrea platform. It processes DICOM 3.0 CT angiographic images to assist cardiologists and radiologists in cardiac evaluation. The software performs semi-automatic segmentation of the left ventricle, right ventricle, and left atrium, identifying long axis and mitral valve boundaries across multiple phases. It calculates global metrics (e.g., ejection fraction, cardiac output, myocardial mass) and regional metrics (e.g., wall motion, polar plots). Used in medical facilities on radiology workstations, the device provides clinicians with quantitative data and visual reports to aid in diagnosing and managing cardiovascular disease. It benefits patients by providing non-invasive, automated functional assessments of multiple heart chambers.

Clinical Evidence

No clinical studies were required. Evidence consists of bench testing, including software verification (performance and safety testing) and validation (simulated usability testing by experienced medical professionals).

Technological Characteristics

Software-based image processing application for radiology workstations. Operates on DICOM 3.0 compliant CT datasets. Features semi-automatic segmentation, multi-planar reformatting (MPR), and automated cardiac parameter calculation. Complies with NEMA PS 3.1-3.20 (DICOM), ISO 14971:2007 (Risk Management), and IEC 62304:2006 (Software Life Cycle).

Indications for Use

Indicated for cardiologists and radiologists to assess cardiac function in patients with suspected or known cardiac diseases using CT studies of the heart.

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

Vitrea 2, version 3.7 Medical Image Processing Software - Cardiac Functional Analysis (K043333)
CardIQ Function Xpress (K073153)

Related Devices

K023760 — CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B · Toshiba America Medical Systems, In.C · Nov 22, 2002
K073153 — CARDIQ FUNCTION XPRESS · GE Medical Systems SCS · Feb 26, 2008
K241038 — Cardiac CT Function Software Application · Circle Cardiovascular Imaging · Jun 7, 2024
K080575 — CORRIDOR4DM · Invia · May 13, 2008
K013422 — CARDIQ FUNCTION · GE Medical Systems · Oct 30, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap and create a sense of movement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 1. 2014 VITAL IMAGES, INC. PARTHIV SHAH SR. REGULATORY AFFAIRS SPECIALIST 5850 OPUS PARKWAY SUITE 300 MINNETONKA MN 55343 Re: K141302 Trade/Device Name: Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 2, 2014 Received: July 7, 2014 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. Smh.P) for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K141302 # Device Name Vitrea® CT Multi-Chamber Cardiac Functional Analysis (CFA) # Indications for Use (Describe) The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots. # 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) Image /page/2/Picture/15 description: The image shows a signature over the letters FDA. The signature is illegible, but it appears to be written in cursive. The letters FDA are in a light gray color and are in the background. The signature is in black and is in the foreground. 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 Officen 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 large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in smaller, red letters. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context. This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.(c) | Purpose of Submission: | Vital Images, Inc. hereby submits this traditional 510(k) to provide a notification submission of a new software application preset called "CT Multi-Chamber Cardiac Functional Analysis (CFA)". This new application has been added into the Cardiac Functional CT protocol available on the Vitrea platforms to provide cardiac functions of Right Ventricle (RV) and Left Atrium (LA) chambers of heart in addition to the previously cleared cardiac evaluation of Left Ventricle (LV) chamber of heart. | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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: | July 2, 2014 | | Device Name Trade Name: | Vitrea® CT Multi-Chamber Cardiac Functional Analysis (CFA) | | Common Name: | System, Image Processing, Radiological | | Classification Name: | System, Image Processing, Radiological (21 C.F.R. 892.2050, LLZ) | | Regulatory Description: | Picture Archiving and Communications System | # Predicate Devices: | Predicate Device | Manufacturer | FDA 510(k) number | |--------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------| | Vitrea 2, version 3.7 Medical Image Processing Software - Cardiac Functional Analysis (Legally Marketed Device) | Vital Images, Inc. | K043333 | | CardIQ Function Xpress (Legally Marketed Device) | GE Medical Systems SCS | K073153 | {4}------------------------------------------------ Image /page/4/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 letters in "VITAL" are all capitalized except for the "i", which is lowercase and has a dot above it. # Device Description: The Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application is a new post processing licensable software preset available on the Cardiac Functional CT protocol for the Vitrea Platforms. This product can be used in the analysis of CT angiographic images to calculate and display several functional cardiac parameters. The software has the ability to select the chambers of the heart and diastolic and/or systolic phases to evaluate the heart's function. The Vitrea CT Multi-Chamber CFA software application contains both graphic and text report capabilities with predefined templates for ease of use. # Intended Use / Indications for Use: The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, right ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots. # Intended for Disease / Condition / Patient Population: The software assists cardiologists and radiologists during a cardiac evaluation to assess various cardiac functions of patients with suspected or known cardiac diseases. # Substantial Equivalence: The Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application is substantial equivalent to a combination of the predicate Vital Images, Inc. Cardiac Functional Analysis (K043333) and GE Medical Systems SCS CardIQ Function Xpress (K073153) devices and is safe and effective for use. # Intended Use Comparison: # For Cardiac Evaluation of Left Ventricle (LV) Chamber: | Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) (K141302) (Submission Subject) | Vitrea 2, version 3.7 Medical Image Processing Software – Cardiac Functional Analysis (K043333) (Predicate Device-1) | Differences | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------| | Intended Use / Indications for Use: | | | | | Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) (K141302) (Submission Subject) | Vitrea 2, version 3.7 Medical Image Processing Software – Cardiac Functional Analysis (K043333) (Predicate Device-1) | Differences | | | The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, right ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots. | The CT CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CFA option includes semi- automatic heart and left ventricle segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots. | The predicate device-1 does not provide cardiac evaluation of right ventricle and left atrium compared to the subject device. | | | Intended Users: | | | | | Cardiologists and radiologists. | Cardiologists and radiologists. | None | | | Modality Support: | | | | | CT | CT | None | | | For Cardiac Evaluation of Right Ventricle (RV) and Left Atrium (LA) Chambers: | | | | | Vitrea® CT Multi-Chamber Cardiac Functional Analysis (CFA) (K141302) (Submission Subject) | CardIQ Function Xpress (K073153) (Predicate Device-2) | Differences | | | Intended Use / Indications for Use: | | | | | The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, right ventricle, and left atrium ) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots. | CardIQ Function Xpress is intended to provide an optimized noninvasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardIQ Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardIQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-invasive image analysis software package, which aids in the assessment of cardiac function and in determination of cardiovascular disease diagnosis and management. CardIQ Function Xpress is for use on the Advantage Workstation (AW) platform, CT Scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans. | None | | | Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) (K141302) (Submission Subject) | CardIQ Function Xpress (K073153) (Predicate Device-2) | Differences | | | Intended Users: | Cardiologists and radiologists. | Cardiologists and radiologists. | None | | Modality Support: | CT | CT | None | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word, in smaller, red letters, is the phrase "A Toshiba Medical Systems Group Company." The text is centered in the image. {6}------------------------------------------------ Image /page/6/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 text is centered and the background is white. {7}------------------------------------------------ Image /page/7/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, lighter font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context. # Technological Characteristics Comparison: | | (Submission Subject) | (Predicate Device-1) | (Predicate Device-2) | | |-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------| | Characteristic | Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) | Vitrea 2, version 3.7 Medical Image Processing Software – Cardiac Functional Analysis | CardIQ Function Xpress | Differences | | | | For Cardiac Evaluation of Left Ventricle (LV) Chamber | For Cardiac Evaluation of Right Ventricle (RV) and Left Atrium (LA) Chambers | | | | (K141302) | (K043333) | (K073153) | | | Device Description: | | | | | | Input Data: | | | | | | Characteristic | (Submission Subject) | (Predicate Device-1) | (Predicate Device-2) | Differences | | Characteristic | Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) | Vitrea 2, version 3.7 Medical Image Processing Software – Cardiac Functional Analysis | CardIQ Function Xpress | Differences | | | | For Cardiac Evaluation of Left Ventricle (LV) Chamber | For Cardiac Evaluation of Right Ventricle (RV) and Left Atrium (LA) Chambers | | | | (K141302) | (K043333) | (K073153) | | | Use in the analysis of CT angiographic images to calculate and display analysis of several functional cardiac parameters | Yes | Yes | Yes | None | | DICOM 3.0 compliant image data | Yes | Yes | Yes | None | | Where Used: | | | | | | Medical facility | Yes | Yes | Yes | None | | User Interface: | | | | | | Designed for use on a radiology workstation | Yes | Yes | Yes | None | | Loading DICOM Datasets: | | | | | | Processes multi-phase, multi-slice cardiac CT images | Yes | Yes | Yes | None | | Characteristic | (Submission Subject) | (Predicate Device-1) | (Predicate Device-2) | Differences | | | Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) | Vitrea 2, version 3.7 Medical Image Processing Software – Cardiac Functional Analysis | CardIQ Function Xpress | | | | | For Cardiac Evaluation of Left Ventricle (LV) Chamber | For Cardiac Evaluation of Right Ventricle (RV) and Left Atrium (LA) Chambers | | | | (K141302) | (K043333) | (K073153) | | | Provides ability to select Diastolic phase | Yes | Yes | Yes | None | | Provides ability to select Systolic phase | Yes | Yes | Yes | None | | Automatically identifies the long axis across multiple phases | Yes | Yes | Yes | None | | Automatically identifies the plane of the Mitral valve | Yes | Yes | Yes | None | | Segmentation: | | | | | | Semi-automatic segmentation of Left Ventricle (LV) chamber | Yes | Yes | Yes | None | | Semi-automatic segmentation of Myocardium of Left Ventricle (LV) chamber | Yes | Yes | Yes | None | | | (Submission Subject) | (Predicate Device-1) | (Predicate Device-2) | | | Characteristic | Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) | Vitrea 2, version 3.7 Medical Image Processing Software – Cardiac Functional Analysis | CardIQ Function Xpress | Differences | | | | For Cardiac Evaluation of Left Ventricle (LV) Chamber | For Cardiac Evaluation of Right Ventricle (RV) and Left Atrium (LA) Chambers | | | | (K141302) | (K043333) | (K073153) | | | Key Functions: | | | | | | Automatic determination of End Diastolic (ED) and End Systolic (ES) phases by volume | Yes | Yes | Yes | None | | Volume Rendering | Yes | Yes | Yes | None | | Phase Navigator | Yes | Yes | Yes | None | | Semi-automatic determination of Epicardial and Endocardial contours | Yes | Yes | Yes | None | | Automated Calculation of Cardiac Parameters | | | | | | End Diastolic Volume (EDV) | Yes | Yes | Yes | None | | End Systolic Volume (ESV) | Yes | Yes | Yes | None | | | (Submission Subject) | (Predicate Device-1) | (Predicate Device-2) | | | Characteristic | Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) | Vitrea 2, version 3.7 Medical Image Processing Software – Cardiac Functional Analysis | CardIQ Function Xpress | Differences | | | | For Cardiac Evaluation of Left Ventricle (LV) Chamber | For Cardiac Evaluation of Right Ventricle (RV) and Left Atrium (LA) Chambers | | | | (K141302) | (K043333) | (K073153) | | | Stroke Volume (SV) | Yes | Yes | Yes | None | | Stroke Index (SI) | Yes | Yes | Yes | None | | Ejection Fraction (EF) | Yes | Yes | Yes | None | | Cardiac Output (CO) | Yes | Yes | Yes | None | | Myocardial Mass | Yes | Yes | Yes | None | | Wall Motion | Yes | Yes | Yes | None | | Percent Wall Thickening | Yes | Yes | Yes | None | | Myocardial Volume (MV) | Yes | Yes | Yes | None | {8}------------------------------------------------ Image /page/8/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 smaller, red letters. The logo is simple and professional, likely representing a company or organization. {9}------------------------------------------------ Image /page/9/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. The phrase below it provides additional context about the company. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" is lowercase. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL". {11}------------------------------------------------ Image /page/11/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, li…