(54 days)
Not Found
No
The document explicitly states "ViewPoint 6 is not intended to be used as an automated diagnosis system" and there is no mention of AI, ML, or related technologies in the device description or performance studies.
No
The device is described as image archiving and reporting software used for diagnostic interpretation of images, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "serves the purposes of diagnostic interpretation of images" and that the "medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes." The "Device Description" also mentions it is "used for diagnostic interpretation of images and other data" and "enables quick diagnostic reporting."
Yes
The device is described as "image archiving and reporting software" and its functions are entirely software-based (accepting, transferring, displaying, calculating, storing, processing images and data, measuring, annotating, reporting). It explicitly states it "does not control or alter any of the medical devices providing data". While it has hardware requirements and can be accessed via client computers or mobile devices, the device itself is the software application.
Based on the provided information, ViewPoint 6 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- ViewPoint 6's Function: ViewPoint 6 is described as image archiving and reporting software for medical practices and clinical departments. Its primary functions are:
- Diagnostic interpretation of images (specifically diagnostic ultrasound).
- Electronic documentation of examinations.
- Generation of medical reports.
- Displaying, calculating, storing, and processing medical images and data.
- Enabling measurement and annotation of images.
- Lack of Specimen Analysis: The description clearly states that ViewPoint 6 works with medical images (ultrasound scans) and clinical data. There is no mention of analyzing biological specimens.
Therefore, ViewPoint 6 falls under the category of medical image management and reporting software, not an IVD device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Imaging Modalities (scanners), primarily for diagnostic ultrasound.
Anatomical Site
Not Found
Indicated Patient Age Range
All patient types
Intended User / Care Setting
medical practices and in clinical departments as well as remote support locations with MobileConnect. Intended for professional use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software was evaluated as recommended in the 2023 FDA guidance document "Content of Premarket Submissions for Device Software Functions." The ViewPoint 6 application was developed following the GE HealthCare Quality Management System. The following activities were successfully completed:
Risk Analysis / Management Requirements Reviews Design Reviews Testing on unit level (Module Verification) Integration testing (System Verification) Performance testing (Verification & Validation) Safety testing (Verification)
The ViewPoint 6 application has also been subject to the following voluntary standards / non-clinical V&V activities:
IEC 62366-1:2016-10, Medical devices – Part1: Application of usability engineering to medical devices IEC 62304:2015-06, Medical device software – Software life cycle processes NEMA PS 3.1-3.20 (2023e), Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) ISO 14971:2019-12, Medical devices - Application of risk management to medical devices IEC 82304-1:2016-10, Health software - Part 1: General requirement for product safety ISO 15223-1:2021-07, Medical devices – Symbols to be used with information to be supplied by the manufacturer ISO 20417:2021-04, Medical devices – Information to be supplied by the manufacturer
Successful completion of design verification and validation testing was performed to confirm that software and user requirements have been met.
Cybersecurity was evaluated as recommended in the 2023 FDA guidance document “Cybersecurity in Medical Devices: Quality Systems Considerations and Content of Premarket Submissions."
Interoperability was evaluated as recommended in the 2017 FDA guidance document "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices."
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Healthcare GmbH % Brandon O'Shea Sr. Regulatory Affairs Manager GE HealthCare 9900 Innovation Drive Wauwatosa, WI 53225
July 2, 2024
Re: K241300
Trade/Device Name: ViewPoint 6 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: May 8, 2024 Received: May 9, 2024
Dear Brandon O'Shea:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Jessica Lamb
Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
ViewPoint 6
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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/0 description: The image contains the GE HealthCare logo. The logo consists of the GE monogram on the left and the text "GE HealthCare" on the right. The monogram and text are both in a purple color.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| 807.92(a)(1) – Submitter Information | |
|---|---|
| Date | 08 May 2024 |
| Submitter | GE Healthcare GmbH |
| Oskar-Schlemmer-Straße 11 | |
| 80807 München, Germany | |
| Primary Contact Person | Brandon O'Shea |
| Sr. Regulatory Affairs Manager | |
| GE HealthCare, Ultrasound | |
| Email: brandon.oshea@gehealthcare.com | |
| Ph: (414) 323-3147 | |
| Secondary Contact Person | Gabriel Carniel |
| Regulatory Affairs Specialist | |
| GE HealthCare, Ultrasound | |
| Email: gabriel.carniel@gehealthcare.com | |
| 807.92(a)(2) – Device Information | |
| Device Trade Name | ViewPoint 6 |
| Common/Usual Name | System, Image Processing, Radiological |
| Regulation Name | Medical image management and processing system |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Class | Class II |
| Product Code | LLZ |
| Review Panel | Radiology |
| 807.92(a)(3) – Predicate Device | |
| 510(k) Number | K203677 |
| Manufacturer | GE Healthcare GmbH |
| Predicate Device(s) | ViewPoint 6 |
| The predicate device has not been subject to a design-related recall | |
| 807.92(a)(4) – Device Description |
Device Design
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.
4
Image /page/4/Picture/0 description: The image contains the logo for GE HealthCare. The logo consists of the GE monogram in purple on the left, followed by the text "GE HealthCare" in a sans-serif font, also in purple. The text is aligned horizontally with the monogram, creating a unified brand representation.
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.
Environment of Use
ViewPoint 6 is intended to be utilized across ultrasound care areas and environments.
Principle of Operation and Deployment
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.
807.92(a)(5) - Indications for Use
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.
807.92(a)(6) - Comparison of Intended Use and Technological Characteristics
The table below compares the intended use and technological characteristics of the subject and predicate device.
| Specification | Predicate Device
ViewPoint 6 (v6.12)
K203677 | Subject Device
ViewPoint 6 (v6.15)
K241300 |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population | All patient types | All patient types |
| Environment of Use | ViewPoint 6 is intended to be used in medical
practices and in clinical departments | ViewPoint 6 is intended to be used in medical
practices and in clinical departments as well as
remote support locations with MobileConnect |
| Design | System is based on Windows operating system Central SQL database Native Client to Server System Client communicates to server via CORBA, SQL and files One Software version with configurable languages | System is based on Windows operating system Central SQL database Native Client and Browser Client(s) to Server System Client communicates to server via REST API, SQL and files One Software version with configurable languages |
| Performance | Performance dependent on customer hardware but minimum hardware requirements for acceptable performance are defined in the System Requirements | Performance dependent on customer hardware but minimum hardware requirements for acceptable performance are defined in the System Requirements |
| Compatibility with other devices / Accessories | Compatibility with other devices: EchoPAC Plug-in (K200852) 4D View (K182750) | Compatibility with other devices: EchoPAC Plug-in (K220940) 4D View (K182750) |
| Interfaces | Public (bidirectional interfaces) DICOM Interface to the imaging modality (scanners) DICOM Interface to PACS HL7 Interface HL7 exam data import interface to a laboratory system or Trium CTG Online BDT/GDT Interface HTTPS+SOAP (only available in Sweden) Private (service/non-public interfaces) TCP+TLS (SQL) TCP (DICOM Fast Routing) | Public (bidirectional interfaces) DICOM + DICOM (TLS) Interface to the imaging modality (scanners) DICOM Interface to PACS HL7 Interface HL7 exam data import interface to a laboratory system or Trium CTG Online BDT/GDT Interface HTTPS+SOAP (only available in Sweden) Private (service/non-public interfaces) TCP+TLS (SQL) TCP (DICOM Fast Routing) FHIR Interface (service/non-public) HTTPS (REST, WAMP, WS, WebDAV) |
| Data Sources /
Connectivity / Outputs | Data Sources (inputs) Imaging Modalities (scanners) Electronic Health Record (EHR/HIS) Picture Archiving and Communication System (PACS) General HL7 connected health systems Connectivity & Output Fax Device Network Attached Storage Imaging Modalities (Scanners) Electronic Health Record (EHR/HIS) Picture Archiving and Communication System (PACS) | Data Sources (inputs) Imaging Modalities (scanners) Electronic Health Record (EHR/HIS) Picture Archiving and Communication System (PACS) General HL7 connected health systems Connectivity & Output Fax Device Network Attached Storage Imaging Modalities (Scanners) Electronic Health Record (EHR/HIS) Picture Archiving and Communication System (PACS) |
| Image Management | Ability to capture and view images Ability to handle DICOM and other image formats (JPG and TIF) but convert all images to DICOM for archiving Manage single images as well as image sequences and volume data Arrange images in an exam Select images to include in a report Take measurements on images Add annotations to images Adjust image parameters | Ability to capture and view images Ability to handle DICOM and other image formats (JPG and TIF) but convert all images to DICOM for archiving Manage single images as well as image sequences and volume data Arrange images in an exam Select images to include in a report Take measurements on images Add annotations to images Adjust image parameters |
| | EchoPAC | EchoPAC |
| | Reporting Module Areas | Reporting Module Areas |
| | • Obstetrics | • Obstetrics |
| | • Maternity Documentation | • Maternity Documentation |
| Examination
Management | • Gynecology | • Gynecology |
| | • Breast Ultrasound | • Breast Ultrasound |
| | • Abdomen and Small Parts | • Abdomen and Small Parts |
| | • Endoscopy | • Endoscopy |
| | • Vascular | • Vascular |
| | • Echocardiography | • Echocardiography |
| | • General Report | • General Report |
| | | Point of Care Ultrasound (POCUS) |
| | • Ability to generate reports which include
exam results, images and graphs | • Ability to generate reports which include
exam results, images and graphs |
| | • Ability to create exam templates for exam
types and care areas or specific departments | • Ability to create exam templates for exam
types and care areas or specific departments |
| | • Ability to set default templates for specific
exam types | • Ability to set default templates for specific
exam types |
| Report Editing and
Management | • Capability to print or fax reports to specific
contact lists | • Capability to print or fax reports to specific
contact lists |
| | • Ability to auto-fill a report with selected
information from a prior study or other values
within a report | • Ability to auto-fill a report with selected
information from a prior study or other values
within a report |
| | • Dark mode reports for light-reduced
environments | • Dark mode reports for light-reduced
environments |
| | • Gestational age | • Gestational age |
| | • Physical patient status calculations (BMI,
PI/RI for Doppler values, etc.) | • Physical patient status calculations (BMI,
PI/RI for Doppler values, expanded
automated calculation for Surface Area by
Haycock BSA formula, etc.) |
| | • Gynecology reporting | • Gynecology reporting |
| | o Ovarian tumor classification according to
IOTA LR2 Model | o Ovarian tumor classification according to
IOTA LR2 Model |
| | o Ovarian tumor classification according to
IOTA Simple Rules Model | o Ovarian tumor classification according to
IOTA Simple Rules Model |
| | o IOTA ADNEX Model (Ovarian Tumor
Analysis Model of IOTA medical group) | o IOTA ADNEX Model (Ovarian Tumor
Analysis Model of IOTA medical group) |
| | o Carotid arteries ultrasound exam
(extracranial): Automated calculation based
on Peak systolic and End-diastolic
velocities index | o Carotid arteries ultrasound exam
(extracranial): Automated calculation based
on Peak systolic and End-diastolic
velocities index (including Sr. Mary
Ratio; ICA prox PSV/CCA distal EDV
ratio) |
| Calculation & Analysis
(within Examination
Management) | • Echocardiography and Vascular ultrasound
reporting: | • Echocardiography and Vascular ultrasound
reporting: |
| | o Standard calculations like
Echocardiography and Doppler automated
calculation | o Standard calculations like
Echocardiography and Doppler automated
calculation |
| | o Echocardiography Reporting
■ Support of Z-Scores | o Echocardiography Reporting
■ Support of Z-Scores (including
publications from Pediatric Heart
Network) |
| | • Head and Neck Reporting | ■ Automated simple
Echocardiography measurement
calculations such as indexed values
(over BSA) |
| | o Automated calculations | ■ Automated report generation for
echocardiography reporting based
on normalized value references |
| | o ACR TI-RADS Thyroid Risk-Stratification
System | |
| | • Obstetrics reporting | |
| | | Head and Neck Reporting Automated calculations ACR TI-RADS Thyroid Risk-Stratification System Thyroid nodules overview table (trending table for thyroid lesion sizes, location and TI-RADS grading) Obstetrics reporting (with extended fetal biometry charts and graphs) |
| Data Privacy and
Security | Centralized user management through link to Microsoft Active Directory by LDAP Database Encryption SmartCard authentication Clear short time store (STS) per station on user logoff LDAP Support FileShare CORBA | Centralized user management through link to Microsoft Active Directory by LDAP Database Encryption SmartCard authentication Clear short time store (STS) per station on user logoff LDAP Support REST API DICOM (TLS) support enabled |
| Other Functions
(non-device functions) | Administrate Appointments (ability to schedule appointments) Coding and billing Order Management Contact Management User Management Analytics | Administrate Appointments (ability to schedule appointments) Coding and Billing Order Management Contact Management User Management Analytics Automatic Assignment of Studies to an Exam |
| User Interfaces | ViewPoint 6 Native Client (PC) | ViewPoint 6 Native Client (PC) ViewPoint 6 Browser Client(s) WebConnect Client (PC/Tablet) MobileConnect Client (Tablet/Phone) |
| Supported Operating
System(s) | Operating System(s) Native Client: Windows 8.1, Windows 10, Windows Server 2012, Windows Server 2016, Windows Server 2019 | Operating System(s) Native Client: Windows 10, Windows 11, Windows Server 2016, Windows Server 2019, Windows Server 2022 Operating System(s) Browser Client (WebConnect): Mozilla Firefox (minimum version 103.2) Microsoft Edge Extended Stable Channel: Version 105.0.1343.42 Google Chrome Version 105.0.5195.127 Operating System(s) Browser Client (MobileConnect): iOS - Apple Safari: Version 16.3 and above Android - Google Chrome Version 111 and above |
5
Image /page/5/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a circular symbol with intertwined letters on the left and the text "GE HealthCare" on the right. The color of the logo is a shade of purple.
6
Image /page/6/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in a simple, sans-serif font, also in purple. The logo is clean and modern, reflecting the company's focus on healthcare technology and innovation.
7
Image /page/7/Picture/0 description: The image contains the GE HealthCare logo. The logo consists of the GE monogram on the left and the text "GE HealthCare" on the right. The monogram and text are both in a purple color.
The proposed ViewPoint 6 application is substantially equivalent to the ViewPoint 6 (K203677) application with regards to intended use, capabilities, technological characteristics, security characteristics, safety and effectiveness.
The proposed ViewPoint 6 application employs the same fundamental scientific technology as its predicate device.
8
Image /page/8/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" monogram on the left. To the right of the emblem is the text "GE HealthCare" in a simple, sans-serif font. The color of the logo and text is a shade of purple.
| 807.92(b)(1) - Performance Testing | |
|---|---|
| Summary of Non-Clinical | |
| Tests | Software was evaluated as recommended in the 2023 FDA guidance |
| document "Content of Premarket Submissions for Device Software | |
| Functions." The ViewPoint 6 application was developed following | |
| the GE HealthCare Quality Management System. The following | |
| activities were successfully completed: | |
| Risk Analysis / Management Requirements Reviews Design Reviews Testing on unit level (Module Verification) Integration testing (System Verification) Performance testing (Verification & Validation) Safety testing (Verification) | |
| The ViewPoint 6 application has also been subject to the following | |
| voluntary standards / non-clinical V&V activities: | |
| IEC 62366-1:2016-10, Medical devices – Part1: Application | |
| of usability engineering to medical devices IEC 62304:2015-06, Medical device software – Software life | |
| cycle processes NEMA PS 3.1-3.20 (2023e), Digital Imaging and | |
| Communications in Medicine (DICOM) Set (Radiology) ISO 14971:2019-12, Medical devices - Application of risk | |
| management to medical devices IEC 82304-1:2016-10, Health software - Part 1: General | |
| requirement for product safety ISO 15223-1:2021-07, Medical devices – Symbols to be used | |
| with information to be supplied by the manufacturer ISO 20417:2021-04, Medical devices – Information to be | |
| supplied by the manufacturer | |
| Successful completion of design verification and validation testing | |
| was performed to confirm that software and user requirements have | |
| been met. | |
| Cybersecurity was evaluated as recommended in the 2023 FDA | |
| guidance document “Cybersecurity in Medical Devices: Quality | |
| Systems Considerations and Content of Premarket Submissions." | |
| Interoperability was evaluated as recommended in the 2017 FDA | |
| guidance document "Design Considerations and Pre-market | |
| Submission Recommendations for Interoperable Medical Devices." |
9
Image /page/9/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, circular design, and the text is in a clean, sans-serif font.
| No additional testing was required beyond the testing per the
standards and the verification testing from the Software/Firmware
| Section to support substantial equivalence. | |
|---|---|
| 807.92(b)(2) – Summary of Clinical Tests | |
| Summary of Clinical Tests | 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. |
| 807.92(b)(3) - Conclusion | |
The performance data described above demonstrate that the proposed ViewPoint 6 application is as safe and effective as the predicate device and supports a determination of substantial equivalence.