PRISM XPVT SYSTEM (210823)

K964712 · Philips Medical Systems (Cleveland), Inc. · KPS · Feb 21, 1997 · Radiology

Device Facts

• Record ID: K964712
• Device Name: PRISM XPVT SYSTEM (210823)
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: KPS · Radiology
• Decision Date: Feb 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The Prism XPVT system is a new gantry for a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions.

Device Story

Prism XPVT is a gantry for gamma camera systems; used for diagnostic imaging of organs and lesions. Operated by trained healthcare professionals in nuclear medicine departments. Device integrates hardware and software with existing gamma camera systems to facilitate imaging. Output consists of diagnostic images used by clinicians to assess organ/lesion status. Benefits include improved diagnostic capabilities for nuclear medicine procedures. Safety verified via electrical standards (IEC-601 or UL-544) and bench testing of image quality performance.

Clinical Evidence

Bench testing only. Validation of image quality performance conducted via laboratory tests to ensure compliance with development specifications.

Technological Characteristics

Gantry for gamma camera system. Electrical safety certified to IEC-601 or UL-544. Includes hardware and software components for integration with gamma camera systems.

Indications for Use

Indicated for diagnostic imaging of organs and lesions in patients undergoing nuclear medicine 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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K964712
FEB 20 1997

# PICKER INTERNATIONAL 510(k) NOTICE

## PRISM XPVT 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 XPVT system.

The Prism XPVT system is a new gantry for 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 XPVT 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 XPVT 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 XPVT 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 XPVT. In addition, all information contained in this 510(k) Notice is accurate and complete.

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