ALLEGRO IMAGING SYSTEM

K033782 · Philips Medical Systems (Cleveland), Inc. · KPS · Dec 19, 2003 · Radiology

Device Facts

• Record ID: K033782
• Device Name: ALLEGRO IMAGING SYSTEM
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: KPS · Radiology
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

Device Story

Allegro Imaging System is a PET scanner for clinical imaging in fixed or mobile environments. It acquires, processes, and displays 3D static, gated, and dynamic images of biochemical and metabolic processes. Input consists of signals from positron and single photon emitting radioisotopes within the patient. The system performs attenuation and non-attenuation correction to produce images for physician interpretation. Used in clinical settings by medical personnel to assist in diagnosis and clinical decision-making. Enhancements in this version include improved DICOM functionality, patient positioning, and cardiac imaging/analysis.

Clinical Evidence

Bench testing only. System performance measured in accordance with NEMA NU-2 standards. Electrical and mechanical safety verified via certification to IEC 60601-1 series standards.

Technological Characteristics

PET imaging system; supports static, gated, and dynamic image reconstruction. Connectivity includes DICOM functionality. Performance adheres to NEMA NU-2 standards. Electrical/mechanical safety per IEC 60601-1 series.

Indications for Use

Indicated for PET imaging to produce images of anatomical distributions of single photon and positron emitting radioisotopes within the head, body, or total body for interpretation by medical personnel.

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

• Allegro Imaging System (K003434)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### General Information

#### Submitter/ Contact Person: A.

| Philips Medical Systems (Cleveland), Inc.<br>595 Miner Rd.<br>Cleveland, OH 44143 | Christof Littwitz<br>Tel: [phone]<br>Fax: [phone] |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Device Trade Name: Allegro Imaging System | |

| B. | Device Trade Name: | Allegro Imaging System |
|----|----------------------|--------------------------------------------------|
| | Common Name: | Positron Emission Tomography |
| | Classification Name: | System, Emission Computed Tomography, (892.1200) |
| | Device Class: | 21CFR 892.1200, Class II |
| | Product Code: | 90 KPS |
| C. | Date prepared: | November 24, 2003 |
| D. | Predicate Device: | Allegro Imaging System (K003434, 11/16/2000) |

- Performance Standards: NEMA NU-2 E.
#### F. Intended Use:

The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

#### G. Device Description:

The Allegro Imaging System is a Positron Emission Tomography (PET) system, a nuclear medical imaging system with capabilities to acquire, process, and display clinical images that can be utilized in both conventional, fixed installations or mobile environments. It is intended to produce attenuation and non-attenuation corrected images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the head, body, or total body for interpretation by medical personnel. The system allows the reconstruction of high-resolution, three-dimensional, static, gated, and dynamic images of biochemical and metabolic processes.

#### System Performance Test/ Summary of Studies: H.

To minimize electrical, mechanical and radiation hazards. Philips Medical System adheres to recognized and established industry practice. Electrical and mechanical safety is assured by adherence and certification to the applicable standards in the IEC 60601-1 series. The device performance was measured in accordance with NEMA-NU2 standard.

{1}------------------------------------------------

### Comparison to Predicate Device I.

The Allegro Imaging System software is an evolution of the features and functionalities of the existing Allegro Imaging System (K003434, 11/16/2003). Design modifications include enhancements in DICOM functionality, patient positioning capabilities, and cardiac imaging and analysis. Similarities and differences between the device and its predicate are described within the 510(k) submission.

In conclusion, the device is substantially equivalent to the predicate device based upon similar intended use, technological comparison, and system performance.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Philips Medical Systems, Inc. % Mr. Juergen Welte Responsible Third Party Official TUV Rheinland of North America 1279 Quarry Lane, Suite A PLEASANTON CA 94566

Re: K033782

Trade/Device Name: Allegro Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II

Product Code: 90 KPS Dated: December 2, 2003 Received: December 4, 2003

Dear Mr. Welte:

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 111 (PMA), it may be subject to such 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.

{3}------------------------------------------------

Page 2

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 the 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" (21CFR Part 807.97) you may obtain. 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,

Nancy C. Brygdon

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

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) **NUMBER** (*If Known*): K033782

DEVICE NAME:

Allegro Imaging System

# INDICATIONS FOR USE:

The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

(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 (Optional Format 1-2-96)

David A. Seymore

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