PRISM 3000XPV SYSTEM (210714)

K961577 · Philips Medical Systems (Cleveland), Inc. · KPS · Jul 23, 1996 · Radiology

Device Facts

• Record ID: K961577
• Device Name: PRISM 3000XPV SYSTEM (210714)
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: KPS · Radiology
• Decision Date: Jul 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

This device is intended to be used for diagnostic imaging of organs and lesions.

Device Story

Gamma camera system modification; hardware and software additions to existing gamma camera platform. Used by trained healthcare professionals in nuclear medicine departments for diagnostic imaging of organs and lesions. Input: radiation data from patients; Output: diagnostic images. Clinical decision-making supported by visual analysis of images by nuclear medicine specialists. Benefits: improved diagnostic imaging capabilities for organ and lesion assessment.

Clinical Evidence

Bench testing only. Laboratory tests performed to validate image quality performance against development specifications. No clinical data provided.

Technological Characteristics

Gamma camera system; hardware and software modifications. Electrical safety certified to IEC-601 or UL-544 standards. System intended for diagnostic imaging.

Indications for Use

Indicated for diagnostic imaging of organs and lesions in patients undergoing Nuclear Medicine diagnostic examinations.

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.

Submission Summary (Full Text)

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K 96/577 JUL 23 1996

# PICKER INTERNATIONAL 510(k) NOTICE

## PRISM 3000XPV SYSTEM

### E: SUMMARY OF SAFETY AND EFFECTIVENESS

This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 807.92(c) for the Prism 3000XPV system.

The Prism 3000XPV system is a modification of a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device. This device includes adding hardware and software to a gamma camera system.

Functional specifications and operator’s instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units.

The Prism 3000XPV system is substantially equivalent to legally marketed devices. The system will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations. The Prism 3000XPV system will be certified to electrical safety standards (IEC-601 or UL-544) by a third party organization prior to use on human patients. Labeling (Product Bulletin and Operator’s Manual) will be provided to the user of the equipment.

Laboratory tests will be run to validate the image quality performance of the system. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the Prism 3000XPV to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device.

Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the Prism 3000XPV. In addition, all information contained in this 510(k) Notice is accurate and complete.

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