(59 days)
No
The document describes image archiving, reporting, and processing software, but there is no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No.
The device is described as an "image archiving and reporting software" intended for "diagnostic interpretation of images" and "electronic documentation." Its function is to display, store, and process medical images and data for diagnostic purposes, not to provide therapy or intervene directly in a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images..." and "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."
Yes
The device description explicitly states "ViewPoint 6 is an image archiving and reporting software" and details its functionality as software running on a standard computer with defined hardware requirements. It does not include or require proprietary hardware components for its core function.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases or other conditions. They are used to examine specimens taken from the human body.
- ViewPoint 6's function: ViewPoint 6 is described as image archiving and reporting software primarily for diagnostic ultrasound. Its purpose is to process, display, store, and report on medical images and data obtained from imaging modalities. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for "diagnostic interpretation of images, electronic documentation of examinations... and generation of medical reports primarily for diagnostic ultrasound." This focuses on image-based diagnosis, not laboratory testing of samples.
Therefore, ViewPoint 6 falls under the category of medical imaging software, not In Vitro Diagnostics.
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
primarily for diagnostic ultrasound. (Implied)
medical images (Implied other imaging modalities compatible with DICOM standard)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 is intended for professional use only.
professional use
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)
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.
ViewPoint 6 (K162743)
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.
Voluson E10 (K172342)
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
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W Innovation Drive WAUWATOSA WI 53226
Re: K173456
Trade/Device Name: ViewPoint 6 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 8, 2017 Received: November 9, 2017
Dear Tracey Ortiz:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
January 5, 2018
1
(1-800-638-2041 or 301-796-7100).
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K173456
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 purpostic 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 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a distinctive and recognizable appearance. The logo is simple, yet iconic, representing the multinational conglomerate corporation.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: November 3, 2017 GE Medical Systems Ultrasound and Primary Care Diagnostics, Submitter: 9900 Innovation Drive Wauwatosa, WI 53226
- Primary Contact Person: Tracey Ortiz Regulatory Affairs Director GE Healthcare T:(262)676-6120 F:(414)918-8275
Charlotte K. Munthe Jørgensen Secondary Contact Person: Regulatory Affairs GE Vingmed Ultrasound AS
| Trade Name:
Common/Usual Name:
Classification Names: | ViewPoint 6
PACS / Picture archiving and communications system
Class II |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | Picture archiving and communications system, 21 CFR 892.2050,
LLZ |
| Primary Predicate
Device(s): | ViewPoint 6 (K162743) |
| Reference Predicate
Device(s): | Voluson E10 (K172342) |
| | 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. |
| | Viau Daint C ic for profoccional uco anly and anables quiloy |
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.
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, and the circle has decorative swirls around it.
GE Healthcare 510(k) Premarket Notification Submission
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.
Intended Use/ Indication for Use:
Indications for Use of ViewPoint 6
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.
- Technology: ViewPoint 6 employs the same fundamental scientific technology as its predicate device.
Determination of
Comparison to Predicates
Substantial Equivalence: The proposed ViewPoint 6 is substantially equivalent to the predicate ViewPoint 6 (K162743) with regards to intended use, capabilities, technological characteristics, safety and effectiveness.
Main-19
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Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized, cursive font. The letters are enclosed within a circular frame, and there are decorative swirls or flourishes around the circle, giving it a classic and recognizable appearance.
GE Healthcare
510(k) Premarket Notification Submission
- Adding IOTA LR2 and Simple rules models on the ● proposed ViewPoint 6 device, that was previously cleared on Voluson E10 (K172342).
Summary of Non-Clinical Tests:
The ViewPoint 6 and its applications comply with 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
The following quality assurance measures are applied to the development of the system:
- 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)
Summary of Clinical Tests:
The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the proposed ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.