VIEWPOINT 6

K103458 · GE Healthcare · LLZ · Mar 4, 2011 · Radiology

Device Facts

• Record ID: K103458
• Device Name: VIEWPOINT 6
• Applicant: GE Healthcare
• Product Code: LLZ · Radiology
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The GE ViewPoint is intended 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.

Device Story

ViewPoint 6 is image-archiving and reporting software for medical practices and clinical radiology departments. It acquires medical images and data from medical devices via DICOM or proprietary interfaces; integrates data from third-party systems. Software enables clinicians to display, measure, annotate, and process images; generate and print patient examination reports. Used in clinical settings by healthcare professionals. Enhancements in this version include improved user interface, customization, and configurable language support. Device facilitates diagnostic interpretation and documentation; does not provide automated diagnosis.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical testing including risk analysis, design reviews, unit-level module verification, system integration testing, performance verification, safety testing, and simulated use validation.

Technological Characteristics

Image archiving and reporting software. Operates via DICOM or proprietary interfaces for data acquisition. Features include image processing, measurement, annotation, and report generation. Software-based system; no specific hardware materials or energy sources defined. Complies with voluntary standards for PACS (21 CFR 892.2050).

Indications for Use

Indicated for professional use in medical practices and clinical departments for diagnostic interpretation of images, electronic documentation of examinations (text and images), and generation of medical reports, primarily for diagnostic ultrasound. Not intended as an automated diagnosis system or for use in surgery-related procedures.

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

• ViewPoint 5 (K050943)

Submission Summary (Full Text)

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MAR - 4 2011

GE Healthcare ViewPoint 6 - 510(k) Premarket Notification

## 510(k) Summary

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In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | November 20, 2010 |
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| Submitter: | GE Healthcare [ViewPoint Bildverarbeitung GmbH]<br>Argelsrieder Feld 12<br>Wessling, Germany, 82234<br>T: [phone]<br>F: [phone] |
| Primary Contact Person: | Nicole Landreville<br>USA Premarket Regulatory Affairs Leader<br>GE Healthcare, QARA Regions - Americas<br>3000 North Grandview Boulevard #W450<br>Waukesha, WI, USA, 53188<br>T: [phone]<br>F: [phone] |
| Secondary Contact Person: | Erich Zanner<br>Site QA & Regulatory Affairs Leader.<br>GE Healthcare [ViewPoint Bildverarbeitung GmbH]<br>Argelsrieder Feld 12<br>Wessling, Germany, 82234<br>T: [phone]<br>F: [phone] |
| Device/Trade Name: | ViewPoint 6 |
| Common/Usual Name: | ViewPoint |
| Classification Names:<br>Product Code: | PACS - Picture archiving and communications system<br>LLZ, 892.2050 |
| Predicate Device(s): | ViewPoint 5 [K050943] |

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## GE Healthcare

ViewPoint 6 - 510(k) Premarket Notification

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| Device-Description: | GE ViewPoint 6 is an-image-archiving and reporting software for<br>medical practices and clinical radiological departments used for<br>diagnostic purpose. It incorporates basic features of<br>administration, image and data acquisition from medical devices<br>via DICOM or proprietary interface, data transfer from third party<br>systems, reporting of medical findings, report generation, network<br>interfacing and archiving. Image processing and calculations<br>capabilities are available for images. |
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| | The basis for this submission is a modification to a legally marketed<br>device to incorporate additional features and to modify the wording<br>of the indications for use statement for clarification purposes. The<br>proposed indications for use statement is equivalent to the one from<br>the predicate device. The intended use is identical to the predicate<br>device.<br>The device modifications mainly consist of:<br>- Enhancements to the User Interface for improved usability;<br>- Additional customization capabilities;<br>- Configurable User Interface language. |
| Intended Use: | The GE ViewPoint is intended to accept, transfer, display, store and<br>process medical images and data, including the ability to measure,<br>calculate, annotate and prepare and print patient examination<br>reports primarily for diagnostic ultrasound. |
| Technology: | The ViewPoint 6 employs the same fundamental scientific<br>technology as its predicate devices. |

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## GE Healthcare ViewPoint 6 - 510(k) Premarket Notification

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1. September 19.

| Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br>The ViewPoint 6 and its sub-applications comply with voluntary<br>standards as detailed in Section 9 of this premarket submission. The<br>following quality assurance measures were applied to the<br>development of the system:<br>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)<br>Summary of Clinical Tests:<br>The subject of this premarket submission, ViewPoint 6, did not<br>require clinical studies to support substantial equiva nce. |
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| Conclusion: | GE Healthcare considers the ViewPoint 6 to be as safe, as effective,<br>and performance is substantially equivalent to the predicate<br>devices. |

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration · 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

GE Healthcare % Ms. Nicole Landreville USA Premarket Regulatory Affairs Leader 3000 North Grandview Boulevard #W450 WAUKESHA WI 53188

MAR - 4 2011

Re: K103458

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 20, 2010 Received: December 20, 2010

Dear Ms. Landreville:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S Pastel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: ViewPoint 6

Indications for Use:

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Mry. Slatel
(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103458

Prescription Use (Per 21 CFR 801.109)