4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ

K101166 · GE Healthcare · LLZ · Oct 7, 2010 · Radiology

Device Facts

• Record ID: K101166
• Device Name: 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
• Applicant: GE Healthcare
• Product Code: LLZ · Radiology
• Decision Date: Oct 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

Image Display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.

Device Story

4D-VIEW 9.1 is a standalone software application installed on PCs running Microsoft Windows Vista. It processes GE Ultrasound 3D/4D data sets as input. The software enables clinicians to display, edit, and perform measurements on these ultrasound images; it also supports data storage and transfer via DICOM. Annotations can be added to images. The device is used in clinical settings to assist healthcare providers in diagnostic decision-making by providing visualization and quantitative analysis of ultrasound data. It benefits patients by facilitating the review and interpretation of complex 3D/4D ultrasound examinations.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical testing, including risk analysis, requirements reviews, design reviews, performance verification, and simulated use validation.

Technological Characteristics

Standalone software for PC (Windows Vista). Functions include 3D/4D image display, editing, and measurements. Connectivity via DICOM for data transfer. Complies with voluntary standards for software development and quality assurance.

Indications for Use

Indicated for diagnostic display and measurement of GE Ultrasound 3D/4D data sets across abdominal, obstetrics, gynecology, cardiology, urology, vascular, neurology, small parts, pediatrics, and musculo-skeletal applications.

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 5.0 (K050943)
• Voluson E8 (K061682)

Submission Summary (Full Text)

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K101166
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OCT 07 2010

### 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: April 22, 2010 GE Healthcare, GE Medical Systems Ultrasound and Primary Submitter: Care Diagnostics, LLC. 9900 Innovation Drive 产品 Wauwatosa, WI, USA 53226 Primary Contact Person: Bryan Behn, Regulatory Affairs Manager GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. Phone: [phone] Fax: [phone] Secondary Contact Person: Jim Turner Regulatory Affairs Manager GE Healthcare Phone: [phone] Fax: [phone]D-VIEW 9.1 Device: Trade Name: Common/Usual Name: 4D-VIEW Classification Names: Class II CFR 892.2050, LLZ Picture Archiving and Communication Systems, 21 CFR Product Code: 892.2050 Viewpoint 5.0 K050943 Predicate Device(s): K061682 Voluson E8 4D View 9.1 is a standalone Software product, which can be Device Description: installed only on a PC with Microsoft Windows Vista operating systems: Primary Operating Functions are: · Display and editing of GE Ultrasound 3D/4D data sets · Measurements on displayed image incl. derived calculations which are all based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Urology, Vascular, Neurology, Small Parts, Pediatrics, Musculo-Skeletal (Orthopedics). · Data storage (image, measurement and patient data) · Data transfer to and from remote systems (e.g. via DICOM) · Adding annotations to acquired image Same measurements and calculations are available on the predicate devices Image Display of GE Ultrasound 3D/4D ultrasound data sets for Intended Use: diagnostic purposes including measurements on displayed image.

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K101166
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#### The 4D VIEW 9.1 employs the same fundamental scientific Technology: technology as its predicate devices.

Determination of Substantial Equivalence: ·

## Summary of Non-Clinical Tests:

The 4D VIEW 9.1 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- . Risk Analysis
- Requirements Reviews .
- Design Reviews .
- Performance testing (Verification) .
- Simulated use testing (Validation) .

#### Summary of Clinical Tests:

The subject of this premarket submission, 4D-View 9.1, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the 4D-VIEW 9.1 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

# 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

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226-4856

OCT 07 2010

Re: K101166

Trade/Device Name: 4D-VIEW 9.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 22, 2010 Received: April 26, 2010

Dear Mr. Behn:

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. Ilsting 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 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 (OS) regulation (21 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,

signature

David G. Brown, Ph.D. . Acting 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): K101166

Device Name: 4D-VIEW 9.1

Indications for Use:

Image Display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number 101160