GE DISCOVERY VCT SYSTEM

K050559 · GE Medical Systems · KPS · Mar 17, 2005 · Radiology

Device Facts

• Record ID: K050559
• Device Name: GE DISCOVERY VCT SYSTEM
• Applicant: GE Medical Systems
• Product Code: KPS · Radiology
• Decision Date: Mar 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The GE Discovery VCT System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery VCT is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

Device Story

Integrated PET/CT system; combines Positron Emission Tomography (PET) and multi-slice Computed Tomography (CT) scanners. Inputs: PET radiopharmaceutical distribution data and CT X-ray attenuation data. Operation: CT images used to correct PET emission data for non-uniform attenuation; integrated PET/CT images provide localized anatomical and functional information. Used in clinical settings by trained healthcare professionals (physicians, technologists). Output: Registered anatomical and functional images via graphical user interface. Clinical utility: Assists in evaluation, diagnosis, staging, restaging, and follow-up of lesions, disease, and organ function (e.g., cancer, cardiovascular, brain); supports radiotherapy planning. Can function as stand-alone CT scanner.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate devices.

Technological Characteristics

Integrated PET/CT imaging system. PET component for emission activity; multi-slice CT component for attenuation correction and anatomical localization. Energy source: X-ray (CT) and radiopharmaceuticals (PET). Connectivity: Integrated graphical user interface for image registration. System is a modification of the predicate Discovery ST, utilizing the GE LightSpeed VCT scanner platform.

Indications for Use

Indicated for head and whole-body PET imaging and CT localization in patients requiring assessment of metabolic and physiologic functions, including cancer, cardiovascular disease, and brain dysfunction; also indicated for radiotherapy planning and as a stand-alone multislice CT diagnostic imaging system. For use by trained healthcare professionals.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• GE Discovery ST System (K041543)
• GE Discovery ST System with Alternate Detector Option (K042257)

Submission Summary (Full Text)

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K050559

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# Technologies

MAR 1 7 2005

## 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))

Device Name Proprietary Device Name:

GE Discovery VCT System

February 1, 2005

P.O. Box 414

Milwaukee, Wi 53201 Phone: [phone] FAX: [phone]

Date prepared:

Establishment Name and Registration Number of Submitter GE Healthcare Technologies Name: (Formerly GE Medical Systems) 2126677 Registration Number: Larry Kroger Corresponding Official: GE Healthcare Technologies

Device Classification Classification Code: Panel Identification: Classification Name:

90 KPS/90 JAK Radiology Emission Computed Tomography System/ Computed Tomography System (Per 21CFR 892.1200 and 21CFR 892.1750) PET/CT Imaging System Class II Product

Common Name: Classification Class:

Reason for 510(k) Submission Modification of a legally marketed device.

Identification of Legally Marketed Equivalent Devices K041543 GE Discovery ST System GE Discovery ST System with Alternate Detector Option K042257

#### Device Description

Device Describetion
The Discovery VCT is an integrated multi-slice Computed Tomography and Positron The Discovery VOT 15 an innes. It uses CT images to correct for non-uniform Emission Tomography Seamers and it uses integrated CT and PET images to localize accenduction of the FET images and tomy. Discovery VCT has capabilities for imaging all emission activity in the patient and can provide inherently registered available I ET tracers and of concreation via an integrated graphical user interface. anatomical and ranetional when as a stand-alone head and whole body multislice CT diagnostic imaging system.

General Electric Company P.O. Box 414

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# Technologies

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510(k) Summary of Safety and Effectiveness February 1, 2005 Page 2

### Description of Change or Modification

The Discovery VCT PET/CT System is the same as the Discovery ST system described in 510/k)s K041543 and K042257 except that the PET system is integrated with a different CT system, the GE LightSpeed VCT system.

#### Indications for Use of Device

The GE Discovery VCT System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

The Discovery VCT is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.

The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

#### Conclusion

In the opinion of General Electric Medical Systems, the Discovery VCT System is substantially the same in design, materials, energy sources, and technology, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery ST System.

General Electric Company P.O. Box 414 Milwaukee, WI 53201

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 17 2005

Re: K050559

GE Healthcare Technologies % Mr. Tamas Borsai Medical Division Manager, Third Party Review Program TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Trade/Device Name: GE Discovery VCT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: KPS and JAK Dated: March 3, 2005 Received: March 3, 2005

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have tevewed your bettler ove (1) }
above and have determined the device is substantially equivalent (for the stated in above and nave decemined the ad predicate devices marketed in interstate commerce prior to the enclosure) to tegally manteled problem. Device Amendments, or to devices that have been May 20, 1770, the onlaominent with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with me ket approval application (PMA). You may, therefore, market the do not require approval of a premants 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 either class II (Special Controls) or class III (Premarket If your device is olashilos (500 as the additional controls. Existing major regulations affecting your Apploval), it they be saoject to and regulations, Title 21, Parts 800 to 898. In addition, FDA device can be round announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease be advised that i Driver 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 I cacral statues and regularing but not limited to registration and listing (21 CFR Part 807); labeling Act STEQuirements, modeling practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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

Sincercly yours,

Nancy C. Hogdon

Nancy 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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## STATEMENT OF INDICATIONS FOR USE

K050557 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: GE Discovery VCT System

### Indications for Use

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The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801-109)

OR Over-The-Counter Use

Nancy C. Hodson

(Division Sign-Off Division of Reproductive, Al and Radiological Devices 510(k) Number