Who is the manufacturer of TOMTEC-ARENA?

Tomtec Imaging Systems GmbH filed the 510(k) submission for TOMTEC-ARENA (K201632).

What is the FDA product code for TOMTEC-ARENA?

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

What is the regulatory pathway for TOMTEC-ARENA?

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

Does TOMTEC-ARENA use AI or machine learning?

Yes. TOMTEC-ARENA (K201632) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for TOMTEC-ARENA?

TomTec-Arena TTA2 (K150122); QLAB Advanced Quantification Software (K200974).

Who can help prepare an FDA 510(k) submission like TOMTEC-ARENA?

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.

Can an AI/ML device like TOMTEC-ARENA get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

TOMTEC-ARENA

K201632 · Tomtec Imaging Systems GmbH · LLZ · Aug 14, 2020 · Radiology

Device Facts

Record ID	K201632
Device Name	TOMTEC-ARENA
Applicant	Tomtec Imaging Systems GmbH
Product Code	LLZ · Radiology
Decision Date	Aug 14, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.

Device Story

TOMTEC-ARENA (TTA2) is a clinical software package for reviewing, quantifying, and reporting digital medical data. It operates as a vendor-independent offline solution, compatible with various platforms. The device processes multi-dimensional medical images (e.g., 3D/4D echocardiography) using automated segmentation and speckle tracking algorithms to generate 3D surface models (Beutel) and quantify functional parameters like volumes, strain, and displacement. Used in hospitals, clinics, and physician offices, it assists clinicians in diagnosing conditions such as pulmonary hypertension and heart failure. Output includes quantitative measurements, bullseye plots, and reports, which support clinical decision-making by providing reproducible assessments of cardiac, fetal, and abdominal structures. The software enhances workflow efficiency through automated contour detection and measurement tools.

Clinical Evidence

No clinical testing conducted. Substantial equivalence supported by bench testing, software verification per IEC 62304, and summative usability evaluation per IEC 62366-1.

Technological Characteristics

Software-as-a-medical-device (SaMD). Functions as a clinical software package for image review, quantification, and reporting. Utilizes machine learning algorithms for automated contour detection and 3D surface model generation. Supports DICOM data. Operates on PC/workstation platforms with browser support (TOMTEC ZERO).

Indications for Use

Indicated for patients with suspected cardiovascular, fetal, or abdominal disease requiring quantification and reporting of anatomical structures and function to support physician diagnosis.

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

TomTec-Arena TTA2 (K150122)
QLAB Advanced Quantification Software (K200974)

Related Devices

K150122 — TOMTEC-ARENA TTA2 · Tomtec Imaging Systems GmbH · Feb 13, 2015
K090461 — IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 · Tomtec Imaging Systems GmbH · May 22, 2009
K213544 — TOMTEC-ARENA · Tomtec Imaging Systems GmbH · Jan 6, 2022
K132544 — TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA · Tomtec Imaging Systems GmbH · Nov 25, 2013
K190913 — QLAB Advanced Quantification Software 13 · Philips Health Care · Jun 18, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 14, 2020 TOMTEC Imaging Systems GmbH % Mr. Marc Bergenthal Manager Regulatory Affairs Edisonstrasse 6 Unterschleissheim, Bavaria 85716 GERMANY Re: K201632 Trade/Device Name: TOMTEC-ARENA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 12, 2020 Received: June 16, 2020 Dear Mr. Bergenthal: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201632 Device Name TOMTEC-ARENA Indications for Use (Describe) Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis. 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) | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div style="text-align:left;"> <input checked="true" type="checkbox"/> </div> | <div style="text-align:left;"> <input type="checkbox"/> </div> | iption 06c (Part 21 CFR 801 Subpart D) |_ | 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 logo for TOMTEC. The logo consists of a stylized "T" followed by the word "TOMTEC" in a bold, sans-serif font. The "T" is formed by two thick, intersecting lines, creating a modern and geometric design. ## 510(K) SUMMARY K201632 This 510(k) summary is provided as part of the Premarket Notification in compliance with 21CFR, Part 807, Subpart E, Section 807.92. #### 1) SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON | Primary Contact: | Marc Bergenthal Email: marc.bergenthal@tomtec.de Tel: (+49) 89 32175 555 Fax: (+49) 89 32175 750 | |------------------|-----------------------------------------------------------------------------------------------------------| | Sponsor: | TOMTEC Imaging Systems GmbH Edisonstrasse 6 85716 Unterschleissheim Germany | 2) NAME OF THE DEVICE, INCLUDING THE TRADE OR PROPRIETARY NAME IF APPLICABLE, THE COMMON OR USUAL NAME, AND THE CLASSIFICATION June 12, 2020 NAME, IF KNOWN Date prepared: | Common Name: | Picture archiving and communications system | |----------------------|------------------------------------------------------------| | Proprietary Name: | TOMTEC-ARENA | | Classification Name: | 21 CFR 892.2050, System, Image Processing, Radiological | | Product code: | QIH, Class II | #### 3) INDICATIONS FOR USE Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis. #### 4) DEVICE DESCRIPTION TOMTEC-ARENA (TTA2) is a clinical software package for reviewing, quantifying and reporting digital medical data. The software is compatible with different IMAGE-ARENA platforms and third party platforms. Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes. TTA2 consists of the following optional modules: {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" symbol on the left, followed by the word "TOMTEC" in a bold, sans-serif font. The entire logo is in black and white. - TOMTEC-ARENA SERVER & CLIENT . - . IMAGE-COM/ECHO-COM - REPORTING ● - AutoStrain (LV, LA, RV) ● - . 2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal) - . 4D LV-ANALYSIS - 4D RV-FUNCTION - . 4D CARDIO-VIEW - 4D MV-ASSESSMENT - 4D SONO-SCAN . #### 5) SUBSTANTIALLY EQUIVALENT DEVICES Primary Predicate Device: TomTec-Arena TTA2 K150122 (February 13, 2015) Secondary Predicate Device: QLAB Advanced Quantification Software K200974 (June 03, 2020) TOMTEC Imaging Systems GmbH believes that the TOMTEC-ARENA modifications that are the subject of this 510(k) are substantially equivalent to TomTec-Arena TTA2 (K150122). ### 6) TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES The TOMTEC-ARENA software with the modified modules has the same intended use and technological characteristics as the legally marketed predicate devices. A comparison of the proposed TOMTEC-ARENA application to the currently marketed primary predicate device (TomTec-Arena TTA2) and secondary predicate device (QLAB Advanced Quantification Software) are provided in the tables below: {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" and "Г" next to the word "TOMTEC" in all caps. The logo is in black and white. | Feature | Primary Predicate Device TomTec-Arena (K150122) | Secondary Predicate Device QLAB (K200974) | Subject Device TOMTEC-ARENEA | Discussion / Comment | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | GENERAL COMPARISON Intended Use | TomTec-Arena software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TomTec-Arena is not intended to be used for reading of mammography images. | QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems. | TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | Intended Use of primary and subject device are identical (unchanged)Intended Use/Indications for use of secondary predicate and subject device are comparable and considered equivalent. | | Indications for Use | Indications for use of TomTec-Arena TTA2 software are quantification and reporting of cardiovascular, fetal, abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis | QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems. | Indications for use of TOMTEC- ARENA TTA2 software are quantification and reporting of cardiovascular, fetal, abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis | Indications for use of primary and subject device are identical (unchanged). Intended Use/Indications for use of secondary predicate and subject device are comparable and considered equivalent. | | Anatomical Site | Quantification and reporting of cardiovascular, fetal, and abdominal structures and function. | Quantification of imaging data acquired from ultrasound machines of various anatomical structures and function. | Quantification and reporting of cardiovascular, fetal, and abdominal structures and function. | Identical to primary and secondary predicate. | | where used (hospital, home, ambulance, etc.) | Hospitals, clinics, and physician's offices. | Hospitals, clinics, and physician's offices. | Hospitals, clinics, and physician's offices. | Identical to primary and secondary predicate. | | Design | Software as a medical device | Software as a medical device | Software as a medical device | Identical to primary and secondary predicate. | | 4D RV-FUNCTION | | | | | | Application Description | 4D RV-Function provides a comprehensive evaluation of the right ventricle including volumes and strain analysis. It provides EDV, ESV, RVEF, SV, RVLS, TAPSE and FAC. Distance measurements can also be analyzed. This software delivers a quick and reproducible analysis of the right ventricle, thus | The 3D Auto RV Q-App is an integration of the segmentation engine of the QLAB HeartModel and the TOMTEC-ARENA 4D RV- Function thereby providing a dynamic Right Ventricle clinical functionality. | The 4D RV-Function is a right ventricular quantification tool for routine clinical work, pulmonary hypertension, and right-sided heart failure. The application helps to overcome complexity of right- ventricle analysis by calculating standard values based on a semi- | Revised for clarity. Considered equivalent to primary predicate. No impact to the safety or effectiveness of the device. Comparable and considered equivalent to secondary predicate. This modification to QLAB was cleared by K191647. | | | increasing your diagnostic confidence by visualizing the complexity of the RV shape in 3D. | | automatically generated 3D surface model. | | | SW Version | 2.0 | 15.0 | 3.0 | Updated due to changes to SW code. Integrates HeartModel auto- segmentation technology with 4D RV- Function algorithm for RV border placement. | | Measurements | Volume and function of Right Ventricle | EDVI ESVI | Added: EDVI ESVI | Added measurements are identical to secondary predicate device. | | Export Formats: | As cleared | Beutel value export into .stl and .obj format | Added: Beutel value export into .stl and .obj format | Identical to secondary predicate. Workflow improvements for user convenience. No impact to the safety or effectiveness of the device. | | Contour Generation | 3D surface model is created based on user defined anatomical landmarks. User is able to edit the contour of the surface model. | 3D surface model is created automatically using machine learning algorithms without user interaction. User is able to edit, accept or reject the contours or the anatomical landmarks. | 3D surface model is created automatically using machine learning algorithms without user interaction. User is able to edit, accept or reject the contours or the anatomical landmarks. | Identical to secondary predicate. Workflow improvements for user convenience. No impact to the safety or effectiveness of the device. | | 4D MV-ASSESSMENT | | | | | | Application Description | 4D MV-Assessment is used for comprehensive morphological and functional assessment of the mitral valve. Based on an easy and intuitive workflow the application package generates models of anatomical structures such as MV annulus, leaflet and the closure line. Automatically derived parameters allow quantification of pre- and post- operative valvular function and comparison of morphology. 4D MV- Assessment improves the presentation of anatomy and findings and visualizes the complex morphology and dynamics of the mitral valve. | The 3D Auto MV Q-App is a semi- automatic tool that essentially is an integration of the machine-learning derived segmentation engine of the QLAB HeartModel and the TOMTEC- Arena TTA2 4D MV-Assessment application thereby providing a dynamic Mitral Valve clinical quantification tool. | 4D MV-ASSESSMENT provides a morphological and functional analysis of the mitral valve (MV) using 3D/4D echocardiography data. Models of anatomical structures such as MV annulus, leaflets and the closure line are generated. The derived parameters allow quantification of pre- and post-operative valvular function and a comparison of morphology. | Revised for clarity. Considered equivalent to primary predicate. No impact to the safety or effectiveness of the device. Comparable and considered equivalent to secondary predicate. This modification to QLAB was cleared by K200974- | | SW Version | 2.3 | 15.0 | 2.5 | Updated due to changes to SW code. | | Measurements | As cleared | Prolapse Height Open Coaptation Gap Open Coaptation Width Open Coaptation Area 3D C-shaped Annulus Distal Anterior Leaflet Angle | Added: Prolapse Height Open Coaptation Gap Open Coaptation Width Open Coaptation Area 3D C-shaped Annulus Distal Anterior Leaflet Angle | Identical to secondary predicate. | | Contour Generation | 3D surface model is created based on user defined anatomical landmarks. User is able to edit the contour of the surface model before proceeding with the workflow. | 3D surface model is created semi- automatically using machine learning algorithm without user interaction. User is able to edit, accept, or reject the initial landmark proposals of the mitral valve anatomical locations. | 3D surface model is created semi- automatically using machine learning algorithm without user interaction. User is able to edit, accept, or reject the initial landmark proposals of the mitral valve anatomical locations. | Identical to secondary predicate. Workflow improvements for user convenience in initial model display and landmark proposal. User is still able to edit, accept or reject the contours. No impact to the safety or effectiveness of the device. | | 4D LV-ANALYSIS | | | | | | Application Description | Volume quantification and function analysis of the left ventricle based on 3D data has proven to be more accurate and reproducible than using 2D clips. 4D LV-Analysis is a vendor independent offline solution for 3D speckle tracking. It provides an automated workflow for quantitative and reproducible analysis of left ventricular deformation and global strain values. 4D LV Function is a basic application for the assessment of left ventricular volumes, EF and GLS while 4D LV Analysis allows for advanced investigations including twist, regional strain and deformation analysis. Results are mapped onto the LV Beutel surface for clear visualization. All results can be stored and exported. | The Dynamic HeartModel (DHM) provides automatic 3D anatomical borders and left ventricle (LV) and left atrium (LA) border tracking across all frames of the cardiac cycle or cycles. | 4D LV-ANALYSIS provides morphological and functional analyses of the left ventricle. Based on 3D echo datasets a 4D model (Beutel) is generated that represents the cavity of the LV and optionally also the LA. Volumes, Strain and Displacement are quantified on a global and segmental level. | Revised for clarity. Considered equivalent to primary predicate. No impact to the safety or effectiveness of the device. Comparable and considered equivalent to secondary predicate. | | SW Version | 3.1 | 15.0 | 3.2 | Updated due to changes to SW code. | | Measurements | As cleared | | | Same technology extended to Atrium (LA Option in 4D LV-Analysis). | | | | LAVmin LAVmax | Added: LA EDV (LA EDVI) LA ESV (LA ESVI) LA PreAV (LA PreAVI) | LA EDV corresponds to LAVmin, and LA ESV corresponds to LAVmax. LA PreAV is based on the same dynamic quantification as LA volume curve (prior to contraction). | | | | LA EF | LA trueEF LA EF LA GLS | LA trueEF uses the same formula as LA EF but different volume values (LA PreAV instead of LAVmax). LA GLS is a well-known parameter and described in clinical literature. Identical to secondary predicate (see "4D RV-Function"). | | Export formats: | As cleared | Beutel value export into .stl and .obj format | Added: Beutel value export into .stl and .obj format | | | Enhancements: | As cleared | n/a | Adapted Bullseye based an ASE2015 guideline. Workflow improvements by removed Beutel revision step & contour proposal and retracking within tracking revision step. | Workflow improvements for user convenience. No impact to the safety or effectiveness of the device. | | AUTOSTRAIN | | | | | | Application Description | n/a - features and functionality were part of IMAGE-COM (AutoSTRAIN Addins) and 2D CPA | AutoStrain LV, LA, RV included | AutoStrain is a quantification tool of global and regional function based on contour detection and tracking. It supports a bull's eye display of Time to Peak Longitudinal Strain and End- Systolic Longitudinal Strain. Further, this CAP provides the calculation of GLS (Global Peak Longitudinal Strain). | Based on cleared Addins of IMAGE- COM and 2D CPA, a dedicated module (CAP) was released. This CAP only includes features and measurements that were already available in IMAGE-COM (and respective Addins), 2D CPA or have been cleared by QLAB. The integration "on cart" requires dedicated CAPs (e.g. for the application layout). This CAP is used in the same clinical context and workflows. No impact to the safety or effectiveness of the device. | | SW Version | n/a - features and functionality were part of IMAGE-COM (AutoSTRAIN Addins) and 2D CPA | 15.0 | 2.1 | No previous SW version as features and functionality were included in IMAGE-COM and/or 2D CPA | | Measurements | n/a - features and functionality were part of IMAGE-COM (AutoSTRAIN Addins) and 2D CPA | | Added: | Measurements available within this CAP were already available in IMAGE-COM/2D CPA or are identical to the secondary predicate (QLAB). No impact to the safety or effectiveness of the device. | | | | LASr ED | LASr ED | | | | | LAScd ED | LAScd ED | | | | | LASct ED | LASct ED | | | | | LASr AC | LASr AC | | | |…