GE LOGIQ WORKS

K063006 · General Electric Co. · LLZ · Nov 2, 2006 · Radiology

Device Facts

• Record ID: K063006
• Device Name: GE LOGIQ WORKS
• Applicant: General Electric Co.
• Product Code: LLZ · Radiology
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

To retrieve and display for reading, diagnostic review, analysis and measurement of digital medical images acquired from DICOM compliant acquisition systems such as CT, MR, PET, X-ray and Ultrasound. Also, for images acquired from GE LOGIQ ultrasound, to process, analyze and manipulate images with the same post acquisition capability as that provided on the GE LOGIQ ultrasound scanner.

Device Story

GE LOGIQworks is an image analysis and review workstation for DICOM-compliant medical images; inputs include CT, MR, PET, X-ray, and ultrasound data. Device enables retrieval, display, diagnostic review, measurement, and analysis. For GE LOGIQ ultrasound images, it provides post-acquisition processing and manipulation capabilities equivalent to those on the original GE LOGIQ scanner. Used in clinical environments by healthcare professionals to facilitate diagnostic decision-making. System sold with or without dedicated computer hardware; operates as a software-based image management tool.

Clinical Evidence

No clinical data required. Device evaluated for conformance to design specifications, software development standards, and system compatibility within intended network environments. Bench testing verified performance against established standards for PACS and medical information management systems.

Technological Characteristics

Software-based image management workstation; DICOM-compliant. Provides post-acquisition processing and manipulation tools for ultrasound images. Conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485:2000 quality systems. Hardware certified to applicable safety standards.

Indications for Use

Indicated for clinicians requiring retrieval, display, diagnostic review, analysis, and measurement of digital medical images (CT, MR, PET, X-ray, Ultrasound) from DICOM-compliant systems. Includes post-acquisition processing and manipulation of images specifically acquired from GE LOGIQ ultrasound scanners.

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

• RadWorks Review (K963699)
• Platinum PACS Workstation (K981217)
• Centricity PACS Plus (K023557)
• Centricity RA 600 (K042525)

Submission Summary (Full Text)

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K063006

Special 510(k) Premarket Notification

GE LOGIQ Works Ultrasound Workstation - Medical Image Management Device September 28, 2006

## Attachment B:

NUV - 2 2006

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c),

| | GE Healthcare |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | General Electric Company<br>P.O. Box 414, Milwaukee, WI 53201 |
| Section a): | |
| 1. Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics<br>PO Box 414<br>Milwaukee, WI 53201 |
| Contact Person: | Allen Schuh,<br>Manager, Safety and Regulatory Engineering<br>Telephone: [phone]; Fax: [phone] |
| Date Prepared: | September 28, 2006 |
| 2. Device Name: | GE LOGIQworks ^™ Ultrasound Image Workstation<br>System, Image Processing, Radiological , 21 CFR 892.2050, 90-LLZ |
| 3. Marketed Device: | RadWorks Review K963699, Platinum PACS Workstation K981217,<br>Centricity PACS Plus K023557 and Centricity RA 600 K042525; all are 90-LLZ |
| 4. Device Description: | The GE LOGIQworks Image Analysis and Review Workstation is optimized for |

4. Device Description: The GE LOGIQ Works Image Analysis and Review Workstation is optimized for ultrasound images that are acquired primarily via the GE LOGIQ family of diagnostic ultrasound systems. It is sold with or without the designated computer hardware.

5. Indications for Use: To retrieve and display for reading, diagnostic review, analysis and measurement of digital medical images acquired from DICOM compliant acquisition systems such as CT, MR, PET, Xray and Ultrasound. Also, for images acquired from GE LOGIQ ultrasound, to process, analyze and manipulate images with the same post acquisition capability as that provided on the GE LOGIQ ultrasound scanner.

6. Comparison with Predicate Device: The GE LOGIQworks™ is of a comparable type and substantially equivalent to the above listed marketed devices with the addition of post acquisition image manipulation and processing capability of the GE LOGIQ 9 Ultrasound. It has equivalent technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has essentially the same intended uses as the predicate device.

## Section b):

1. Non-clinical Tests: The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. It is further verified for system compatibility with the devices with which it communicates. Computer hardware is certified to applicable safety standards.

2. Clinical Tests: None required to confirm safety and effectiveness. However, evaluation in a clinical setting is performed to help assure reliability and compatibility within the intended network environment.

3. Oonclusion: Intended uses and other key features of the device are consistent with traditional clinical practice, FDA guidelines and established methods of handling patient examination images and data. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485:2000 quality systems. The device conforms to applicable medical device safety . startans and compliance is verified through internal and independent quality system audit. PACS devices and medical information management systems in general have accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ or is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering General Electric Company GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226

NOV - 2 2006

Re: K063006

Trade/Device Name: GE LOGIQworks" Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: September 28, 2006 Received: October 21, 2006

Dear Mr. Schuh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booken overy pro promotially equivalent (for the indications for referenced above and nave accemined arketed predicate devices marketed in interstate commerce ass stated in the encreasury that with in the Medical Device Amendments, or to devices that provide with 20, 1778, the endomical with the provisions of the Federal Food, Drug, and Cosmetic nate been roomsermed in a proval of a premarket approval application (PMA). You may, Act (Act) that ao not require apple ful one general controls provisions of the Act. The general therefore, mailive the detice, sabjoct to envirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (500 above) hits on controls. Existing major regulations affecting your Approval), it thay be sabject to Jack at Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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ding and Promoting Public S

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Page 2 --

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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/edriv/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment E

## Indications for Use

- Kor 300 6 510(k) Number (if known):
Device Name: GE LOGIQworks ™

Indications For Use: To retrieve and display for reading, diagnostic review, analysis and measurement of digital medical images acquired from DICOM compliant acquisition systems such as CT, MR, PET, X-ray and Ultrasound.

> Also, for images acquired from GE LOGIQ ultrasound, to process, analyze and manipulate images with the same post acquisition capability as that provided on the GE LOGIQ ultrasound scanner.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Lee Ingram
(Division Sign Off)

(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number