GE VEO RECONSTRUCTION OPTION

K103489 · General Electric Co. · JAK · Sep 9, 2011 · Radiology

Device Facts

• Record ID: K103489
• Device Name: GE VEO RECONSTRUCTION OPTION
• Applicant: General Electric Co.
• Product Code: JAK · Radiology
• Decision Date: Sep 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Veo Reconstruction Option is intended for head and whole body CT scans when higher image quality and/or lower dose acquisitions are desired for challenging cases.

Device Story

Veo Reconstruction Option is a server-based software/hardware add-on for GE CT scanners (initially Discovery CT750 HD). It receives raw CT scan data from the operator console via Ethernet; processes data using an alternate reconstruction method to reduce noise and improve resolution/low-contrast detectability; and returns reconstructed images to the console. Used in clinical settings by radiology staff. Output allows clinicians to perform diagnostic imaging at lower radiation doses or improve image quality in challenging cases. Benefits include potential dose reduction for patients and improved diagnostic utility of low-dose scans.

Clinical Evidence

No clinical data provided. Functional requirements and safety were demonstrated via bench testing and hazard analysis in accordance with IEC 62304 software development lifecycle procedures.

Technological Characteristics

Consists of server hardware and reconstruction software. Connects to CT operator console via dedicated Ethernet. Uses identical CT imaging principles as the predicate. Software development follows IEC 62304 standards. Compliant with 21 CFR 892.1750.

Indications for Use

Indicated for patients of all ages requiring cross-sectional head and body CT imaging. Used for axial and helical (volumetric) acquisitions to reduce image noise, increase resolution, and improve low contrast detectability. Applicable for routine imaging of head, chest, abdomen, and pelvis, including dose reduction and improving image quality of non-diagnostic filtered backprojection images.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• GE Discovery CT750 HD (K081105)

Submission Summary (Full Text)

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K103489

GE Medical Systems, LLC
510(k) Premarket Notification Submission for: GE Veo Reconstruction Option

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# SECTION 5

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SEP - 9 2011

# 510(k) SUMMARY

Summary of Safety and Effectiveness (3 pages) 5.1

5-2

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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The circle has a decorative border with curved, leaf-like shapes around it.

## GE Healthcare GE Medical Systems, LLC

3000 N. Grandview Blvd. Waukesha, WI 53188

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).

| Date Prepared: | June 1, 2011 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare (GE Medical Systems, LLC)<br>3000 N. Grandview Blvd., W-1140<br>Waukesha, WI 53188 |
| Primary Contact: | John Jaeckle<br>Regulatory Affairs Manager, MI & CT<br>GE Healthcare (GE Medical Systems, LLC)<br>Tel: [phone]<br>e-mail: [e-mail] |
| Secondary Contact: | Andrew Menden<br>Regulatory Affairs Leader, MI & CT<br>GE Healthcare (GE Medical Systems, LLC)<br>Tel: [phone], Fax: [phone]<br>e-mail: [e-mail] |

### DEVICE IDENTIFICATION

| Trade Name: | GE Veo Reconstruction Option |
|----------------------|-------------------------------------------------------|
| Common/Usual Name: | Veo |
| Classification Name: | Computed Tomography X-ray System per<br>21CFR892.1750 |
| Product Code: | 90-JAK |
| Predicate Device(s): | GE Discovery CT750 HD (K081105) |

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| Manufacturer /<br>Design Location: | GE Medical Systems, LLC (GE Healthcare)<br>3000 N. Grandview Blvd.<br>Waukesha, WI 53188 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Location: | GE Medical Systems, LLC (GE Healthcare)<br>3000 N. Grandview Blvd.<br>Waukesha, WI 53188 |
| Distributor: | Same as Manufacturer |
| Marketed Devices: | The GE Veo Reconstruction Option when combined with the<br>GE CT system is of comparable type and substantially<br>equivalent to GE Healthcare's currently marketed Computed<br>Tomography X-ray Systems that comply with the same or<br>equivalent standards and having similar intended use. The<br>GE CT system with the integrated GE Veo Reconstruction<br>Option remains compliant with the same standards as the<br>CT system. |

### DEVICE DESCRIPTION

The Veo Reconstruction Option is composed of Server hardware and reconstruction software. The Veo reconstruction Server is connected to the CT system's operator console via a dedicated Ethemet connection to receive raw scan data for processing and send back the reconstructed image data when completed. Additionally, some minor changes to the CT system software are made to include functionality for installation and operation of the Veo Reconstruction Option. The option when used with the Discovery CT750 HD system (K081105) is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market. The product changes are primarily associated with the new reconstruction software and hardware. The Veo Reconstruction Option provides another method for reconstruction to that already provided by the CT system.

The Veo Reconstruction Option is intended for head and whole body CT scans when higher image quality and/or lower dose acquisitions are desired for challenging cases. The GE Veo Reconstruction Option when used with the CT System uses virtually the same materials and identical CT imaging principles as our existing marketed product. Discovery CT750 HD.

#### INTENDED USE

The Veo Reconstruction Option is intended for head and whole body CT scans when higher image quality and/or lower dose acquisitions are desired for challenging cases.

#### INDICATIONS FOR USE

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The Veo reconstruction option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial and Helical (Volumetric) acquisitions for all ages.

When used, it allows for an alternate reconstruction method designed to reduce image noise, increase resolution and improve low contrast detectability in images produced using raw Computed Tomography data from GE CT scanners. The Veo reconstruction option can be used to reduce noise in diagnostic images and also to reduce the dose required for routine imaging, including CT scans of the head, chest, abdomen and pelvis. The Veo reconstruction option may also improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic.

Currently, Veo is for use with the Discovery CT750 HD CT Scanner.

### COMPARISON WITH PREDICATE

The GE Veo Reconstruction Option when used with the CT System uses virtually the same materials and identical CT imaging principles as our existing marketed product. Discovery CT750 HD. The Veo Reconstruction Option provides another method for reconstruction to that already provided by the CT system.

The GE Veo Reconstruction Option when combined with the GE CT system is of comparable type and substantially equivalent to GE Healthcare's currently marketed Computed Tomography X-ray Systems. The Veo Reconstruction Option was developed under GE's Quality System and will be initially introduced as an option for the Discovery CT750 HD system (K081105), The GE CT system when using the GE Veo Reconstruction Option remains compliant with the same standards as the CT system.

### ADVERSE EFFECTS ON HEALTH

The Veo Reconstruction Option is designed and manufactured under the Quality System Regulations, 21 CFR Part 820. Additionally, risk management is employed through hazard analysis, which identifies potential hazards. These hazards are mitigated through adherence to software development lifecycle procedures aligned with IEC 62304 and through product labeling including user instructions. Functional requirements are demonstrated via testing.

#### CONCLUSION

The Veo Reconstruction Option when used with a GE CT system is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market. In addition, when the CT system and the Veo option are combined they remain compliant with the same standards as the CT system alone. The combination of the Veo option and the CT System uses virtually the same materials and identical CT imaging principles as our existing marketed product, Discovery CT750 HD (K081105).

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Image /page/4/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol with three horizontal bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Public Health Service

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

Mr. Andrew Menden Regulatory Affairs Leaser, MI&CT GE Healthcare GE Medical Systems, LLC 3000 N. Grandview Blvd. WAUKESHA WI 53188

ු 2011

Re: K103489

Trade/Device Name: GE Veo Reconstruction Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 1, 2011 Received: June 2, 2011

Dear Mr. Menden:

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, l'isting 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 fruther 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 not the Act or any Federal statutes and regulations administered by other Federal agencies. Your 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 (QS) 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 evenis under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/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 Patel

Mary S. Pastel, Sc.D. 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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# Indications for Use

510(k) Number (if known): K103489

Device Name: GE Veo Reconstruction Option

#### Indications for Use:

The Veo reconstruction option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial and Helical (Volumetric) acquisitions for all ages.

When used, it allows for an alternate reconstruction method designed to reduce image noise, increase resolution and improve low contrast detectability in images produced using raw Computed Tomography data from GE CT scanners. The Veo reconstruction option can be used to reduce noise in diagnostic images and also to reduce the dose required for routine imaging, including CT scans of the head, chest, abdomen and pelvis. The Veo reconstruction option may also improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic.

Currently, Veo is for use with the Discovery CT750 HD CT Scanner.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Mary S. Patil

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103489

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