GE QUASAR NUCLEAR MEDICINE SYSTEM

K022960 · Ge Medical Systems F.I. Haifa · KPS · Sep 19, 2002 · Radiology

Device Facts

• Record ID: K022960
• Device Name: GE QUASAR NUCLEAR MEDICINE SYSTEM
• Applicant: Ge Medical Systems F.I. Haifa
• Product Code: KPS · Radiology
• Decision Date: Sep 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncolgy, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT . Gated SPECT . Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multiisotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation corrcction and functional anatomic mapping.

Device Story

GE Quasar System is a nuclear medicine imaging device performing planar and tomographic imaging (SPECT, Gated SPECT, Whole body SPECT, and camera-based PET/Coincidence Detection). It detects radioisotope tracer uptake in patients. Input data includes single/multi-isotope, multi-peak frame, and list-mode signals. System features include physiological gating, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. Operated by clinicians in diagnostic imaging settings, the system transforms raw radiation detection data into images to assist in clinical decision-making. Benefits include enhanced image quality for diagnostic assessment across oncology, cardiology, and neurology.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Nuclear medicine imaging system (Emission Computed Tomography). Supports planar and tomographic scanning modes. Features include physiological gating, real-time automatic body contouring, and CT-based attenuation correction. Connectivity includes support for multi-isotope/multi-peak frame and list-mode acquisition. System utilizes various collimators for image enhancement.

Indications for Use

Indicated for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in patients requiring diagnostic imaging in oncology, cardiology, neurology, and other clinical applications.

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

• Elscint Apex VariCam (K953801)
• GE Hawkeye Option for Dual-Head Variable Angle Gamma Camera (K991841)
• GE CoDe Option; Volumetric Coincidence Detection (CoDe) Imaging System for VariCam (K962100)

Submission Summary (Full Text)

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1022960

Image /page/0/Picture/1 description: The image shows a black and white logo of GE, which is a well-known multinational conglomerate. The logo is circular in shape and features the letters 'GE' intertwined in a stylized manner. The design is simple yet recognizable, representing the brand's identity.

# SEP 1 9 2002

GE Medical Systems

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

#### 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 10. 807.87(h))

Device Name Proprietary Device Name:

GE Quasar System

| Establishment Name and Registration Number of Submitter | |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name: | ELGEMS Ltd. |
| Date Prepared: | July 11, 2002, revised August 27, 2002 |
| Registration Number: | 9613299 |
| Corresponding Official: | Hemy Neuman, Quality, Safety and<br>Regulatory Manager<br>ELGEMS Ltd.<br>10 Hayozma St.<br>Tirat Hacarmel 30200, ISRAEL<br>[e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Device Classification | |
| Classification Code: | 90 KPS |
| Panel Identification: | Radiology |

Emission Computed Tomography System Classification Name: (per 21CFR 892.1200) Nuclear Medicine Imaging system Common Name: Classification Class: Class II Product

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

## Identification of Legally Marketed Equivalent Devices

Elscint Apex VariCam - K953801 GE Hawkeye Option for Dual-Head Variable Angle Gamma Camera -K991841 GE CoDe Option; Volumetric Coincidence Detection (CoDe) Imaging System

for VariCam (Nuclear Medicine System) - K962100

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the top of the logo.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 9 2002

GE Medical Systems c/o Mr. Heinz Joerg Steneberg Division Manager Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

### Re: K022960

Trade/Device Name: GE Quasar System Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: August 30, 2002 Received: September 6, 2002

Dear Mr. Steneberg:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 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.

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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Пенсу Сводки

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 INTENDED USE

510(k) Number (if known):

K022960

Device Name: GE Quasar System

## Indications for Use

The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncolgy, Cardiology, Neurology and other clinical diagnostic imaging applications.

The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT . Gated SPECT . Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multiisotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation corrcction and functional anatomic mapping.

(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

Yimil le. Sagnm

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