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ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.

ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It is designed with intuitive graphical user interfaces (GUIs) and is based on Microsoft Windows® with defined hardware requirements.

Viewpoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.

ViewPoint 6 supports both a single workstation and a client/browser - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality.

ViewPoint 6 software is a server-based application with client-server architecture, accessed via client computers or mobile devices as well as browser-based systems. Viewpoint 6 is installed on client provided servers within a hospital network.

The software comes with features to view, annotate, measure, calculate, save and retrieve clinical data (including images via DICOM format) to support patient documentation and record keeping related to ultrasound image scans. Additionally, the software is available for patient administrative tasks such as appointment scheduling and exam billing.

This product does not control or alter any of the medical devices providing data across the hospital network.

The provided text is a 510(k) Summary for a medical device called "ViewPoint 6." This type of document focuses on demonstrating substantial equivalence to a predicate device and typically does not contain detailed primary study results with acceptance criteria and specific performance metrics as would be found in a clinical study report. It primarily outlines the scope of V&V activities and voluntary standards adhered to.

Based on the provided text, the following information can be extracted regarding the device performance and acceptance criteria:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in terms of clinical accuracy (e.g., sensitivity, specificity). Instead, it states that:

"Successful completion of design verification and validation testing was performed to confirm that software and user requirements have been met."

This implies that the acceptance criteria are tied to the fulfillment of software and user requirements, which are assessed through various testing activities, but the specific numerical performance metrics are not detailed in this summary. The general statement about "Performance dependent on customer hardware but minimum hardware requirements for acceptable performance are defined in the System Requirements" suggests that performance acceptance is related to system specifications rather than clinical efficacy metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify any sample sizes for a clinical test set, nor does it provide data provenance (e.g., country of origin, retrospective or prospective nature). The V&V activities mentioned (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Performance testing, Safety testing) are typically software engineering and system-level tests and do not involve a clinical test set with patient data for performance evaluation in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No clinical test set is described, and therefore, there is no information about the number or qualifications of experts used to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No clinical test set is described, so no adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document states:

"The similarities and differences between the subject device and the predicate device, were determined not to have a significant impact on the device's performance, the clinical performance, and the actual use scenarios. Therefore, the subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."

This explicitly indicates that no MRMC comparative effectiveness study, or any clinical study, was conducted or deemed necessary for this 510(k) submission. Therefore, there is no information about AI assistance or its effect size on human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as "an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data." The indications for use state it "is not intended to be used as an automated diagnosis system." This confirms it's a tool to assist clinicians, not a standalone diagnostic algorithm. No standalone algorithmic performance study was conducted or mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

As no clinical studies were performed for diagnostic accuracy, no specific ground truth type (expert consensus, pathology, outcomes data, etc.) is mentioned. The V&V activities focused on software and system requirements.

8. The sample size for the training set

The document does not refer to any AI/ML components that would require a training set. Therefore, no training set sample size is provided.

9. How the ground truth for the training set was established

Since no training set is mentioned for AI/ML, there is no information on how its ground truth would be established.

In summary:

This 510(k) submission for ViewPoint 6 primarily relies on demonstrating substantial equivalence to a predicate device (ViewPoint 6 v6.12 K203677) through software validation and verification activities, adherence to voluntary standards, and a comparison of technological characteristics. It explicitly states that clinical studies were not required because the changes from the predicate device were not deemed to have a significant impact on clinical performance. Therefore, detailed information regarding clinical performance acceptance criteria, sample sizes for test or training sets, expert adjudication, or AI performance metrics is not present in this document.

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ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system. ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. It provides different calculations and tools to allow for the assessment of the images and data.

ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference. ViewPoint 6 supports both a single workstation and a client - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read - only functionality

The document provided is a 510(k) Premarket Notification Submission for the GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC's ViewPoint 6 device (K203677). This submission primarily focuses on establishing substantial equivalence to a predicate device (ViewPoint 6, K192917) and a reference device (EchoPAC Software Only, K200852).

Based on the provided information, the 510(k) submission states that clinical studies were not required or performed to support the substantial equivalence of ViewPoint 6. Therefore, there is no detailed study data, acceptance criteria, or performance metrics within this document that would typically be associated with a clinical trial or performance evaluation study specifically proving the device meets certain acceptance criteria through direct testing.

The conclusion explicitly states:
"The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."

"GE Healthcare considers the ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate device."

This means that the manufacturer is asserting the new ViewPoint 6 is functionally equivalent to the previously cleared ViewPoint 6 (K192917) and EchoPAC Software Only (K200852) based on its intended use, technological characteristics, and non-clinical performance (e.g., meeting voluntary standards, software development quality assurance measures).

Therefore, it is not possible to provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text, as such a study was not conducted or reported in this submission.

The document highlights the device's adherence to voluntary standards and internal quality assurance measures in lieu of clinical performance testing for this specific 510(k) submission.

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ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.

ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. It provides different calculations and tools to allow for the assessment of the images and data.

ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.

ViewPoint 6 supports both a single workstation and a client - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read - only functionality.

This FDA 510(k) summary for GE Healthcare's ViewPoint 6 software does not contain the detailed information necessary to complete the requested table and answer the study-related questions. The document states that no clinical studies were required to support substantial equivalence (Page 6).

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This information is derived from clinical studies, which were not performed.
2. Sample size used for the test set and the data provenance: No clinical test set was described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth for a test set was established as no clinical test was conducted.
4. Adjudication method for the test set: Not applicable as no test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, the document explicitly states no clinical studies were required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no algorithm performance study was described. ViewPoint 6 is described as an image archiving and reporting software, not an automated diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Based on the provided document, the ViewPoint 6 device is a Picture Archiving and Communication System (PACS) software tool. The 510(k) submission for ViewPoint 6 relied primarily on non-clinical tests and a comparison to predicate devices, rather than clinical performance studies, to demonstrate substantial equivalence.

The document states:

• "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." (Page 6)
• "GE Healthcare considers the ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate devices." (Page 6)
• The determination of substantial equivalence was based on "intended use, capabilities, technological characteristics, safety and effectiveness" compared to predicate devices (ViewPoint 6, K173456, and reference devices Voluson E10, K192159 and Versana Balance, K191792). (Page 5)
• The summary focuses on "Non-Clinical Tests" such as compliance with voluntary standards (IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20 DICOM, ISO 14971, IEC 82304-1) and quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing). (Pages 5-6)

Therefore, the requested information regarding acceptance criteria and performance data from a clinical study cannot be extracted from this document, as no such study was conducted or presented in this 510(k) summary.

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ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.

ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.

ViewPoint 6 supports both a single workstation and a client-server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) premarket notification for a medical device called "ViewPoint 6." This document primarily discusses the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical tests performed to ensure compliance with relevant standards.

Specifically, the document states: "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." This means that no clinical study was conducted to demonstrate the device's performance against specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used for ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images. drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system. ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data.

ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.

ViewPoint 6 supports both a single workstation and a clientserver setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality.

The provided text contains information about a 510(k) submission for the ViewPoint 6 device, which is a Picture Archiving and Communications System (PACS). However, it explicitly states, "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."

Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance. It focuses on non-clinical tests (compliance with standards, quality assurance measures).

Here's what can be extracted based on the prompt's requirements, highlighting the lack of relevant clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission states that clinical studies were not required to support substantial equivalence. Therefore, there are no reported acceptance criteria or device performance metrics from a clinical study.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set was used as clinical studies were not required.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical test set requiring ground truth established by experts was used.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A MRMC comparative effectiveness study was not performed as clinical studies were not required.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-loop Performance) was Done

Not applicable. The device is a PACS system for diagnostic interpretation and reporting, not an automated diagnosis system. The submission explicitly states: "ViewPoint 6 is not intended to be used as an automated diagnosis system." Therefore, a standalone algorithm performance study is not relevant in the context of this device.

7. The Type of Ground Truth Used

Not applicable. No clinical test set requiring ground truth was used.

8. The Sample Size for the Training Set

Not applicable. The device is a PACS software, not an AI/ML diagnostic algorithm that would typically involve a "training set" for model development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, there is no mention of a training set or associated ground truth.

Summary of Non-Clinical Tests and Quality Assurance (as provided in the document):

The device complies with the following voluntary standards:

• IEC 62366-1:2015 Medical devices Application of usability engineering to medical devices
• IEC 62304:2006, Medical device software Software life cycle process
• NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
• ISO 14971:2012 Medical Devices Application of risk management to medical devices

Quality assurance measures applied to the development of the system include:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Final Acceptance Testing (Design Validation and Service Validation)
• Performance testing (Verification)
• Safety testing (Verification)

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ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes.

ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.

ViewPoint is not intended to operate medical devices in surgery related procedures.

GE ViewPoint 6 is an-image-archiving and reporting software for medical practices and clinical radiological departments used for diagnostic purpose. It incorporates basic features of administration, image and data acquisition from medical devices via DICOM or proprietary interface, data transfer from third party systems, reporting of medical findings, report generation, network interfacing and archiving. Image processing and calculations capabilities are available for images.

The basis for this submission is a modification to a legally marketed device to incorporate additional features and to modify the wording of the indications for use statement for clarification purposes. The proposed indications for use statement is equivalent to the one from the predicate device. The intended use is identical to the predicate device.
The device modifications mainly consist of:

• Enhancements to the User Interface for improved usability;
• Additional customization capabilities;
• Configurable User Interface language.

The provided document is a 510(k) Premarket Notification for GE Healthcare's ViewPoint 6, an image archiving and reporting software for medical practices and clinical radiological departments. The document focuses on demonstrating substantial equivalence to a predicate device (ViewPoint 5) and does not describe a study involving AI or specific acceptance criteria for a device's performance in terms of diagnostic accuracy or a similar clinical metric.

Therefore, many of the requested details, such as a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not available in this document.

Here's what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable / Not available. The document states that ViewPoint 6 did not require clinical studies. The "acceptance criteria" here are related to regulatory compliance and demonstrating substantial equivalence to a predicate device, rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI device. The study performed involved non-clinical tests to verify compliance with voluntary standards and ensure quality assurance.

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable / Not available. As no clinical studies were performed, there is no test set in the context of diagnostic performance evaluation. The "tests" mentioned are for software verification and validation (e.g., unit, integration, performance, safety, simulated use testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable / Not available. No ground truth for diagnostic performance was established for a test set as no clinical studies were performed.

4. Adjudication Method for the Test Set:

• Not applicable / Not available.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• Not applicable. This device is an image archiving and reporting software, not an AI-powered diagnostic tool for assisting human readers. The document explicitly states it "is not intended to be used as an automated diagnosis system."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is software for image management and reporting, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. No clinical ground truth was established for diagnostic performance. The "ground truth" in the context of this submission refers to the successful completion of software development lifecycle activities and adherence to established standards and requirements for software functionality and safety.

8. The Sample Size for the Training Set:

• Not applicable / Not available. This is not an AI/machine learning device that relies on a training set for model development.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable / Not available.

Summary of the Study and Device Information (as per document):

• Device Name: ViewPoint 6
• Device Type: Image archiving and reporting software for medical practices and clinical radiological departments.
• Intended Use: "To accept, transfer, display, store and process medical images and data, including the ability to measure, calculate, annotate and prepare and print patient examination reports primarily for diagnostic ultrasound." It also explicitly states: "ViewPoint is not intended to be used as an automated diagnosis system."
• Study Performed: Non-clinical tests were conducted to comply with voluntary standards and apply quality assurance measures to the development of the system. These included:
  • Risk Analysis
  • Requirements Reviews
  • Design Reviews
  • Testing on unit level (Module verification)
  • Integration testing (System verification)
  • Performance testing (Verification)
  • Safety testing (Verification)
  • Simulated use testing (Validation)
• Conclusion of Study: "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." The non-clinical tests were deemed sufficient to demonstrate that ViewPoint 6 is as safe, as effective, and its performance is substantially equivalent to the predicate device (ViewPoint 5).

In essence, the ViewPoint 6 submission is for a software update to an existing PACS (Picture Archiving and Communications System) type device, not for an AI diagnostic device. Its regulatory pathway leveraging substantial equivalence to a predicate device and focusing on non-clinical software testing reflects its classification and intended use as a medical image management system, not a device making diagnostic interpretations.

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