Who is the manufacturer of XENON OPTION TO PRISM 3000?

Philips Medical Systems (Cleveland), Inc. filed the 510(k) submission for XENON OPTION TO PRISM 3000 (K955484).

What is the FDA product code for XENON OPTION TO PRISM 3000?

KPS. It is classified under 21 CFR 892.1200 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for XENON OPTION TO PRISM 3000?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like XENON OPTION TO PRISM 3000?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XENON OPTION TO PRISM 3000

K955484 · Philips Medical Systems (Cleveland), Inc. · KPS · Mar 29, 1996 · Radiology

Device Facts

Record ID	K955484
Device Name	XENON OPTION TO PRISM 3000
Applicant	Philips Medical Systems (Cleveland), Inc.
Product Code	KPS · Radiology
Decision Date	Mar 29, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1200
Device Class	Class 2

Intended Use

The Xenon Option to the Prism 3000 system is a modification of a gamma camera system. This device is intended to be used for diagnostic brain imaging.

Device Story

Modification to Prism 3000 gamma camera system; includes xenon delivery system, xenon probe, system interface, and software. Operated by trained nuclear medicine healthcare professionals in clinical settings. Device facilitates diagnostic brain imaging by delivering xenon gas and capturing resulting radiation signals via gamma camera. Output used by physicians to diagnose brain anomalies. Safety certified to IEC-601 standards.

Clinical Evidence

Clinical tests demonstrated effectiveness in diagnosing brain anomalies. Performance confirmed to meet development specifications.

Technological Characteristics

Gamma camera system with integrated xenon delivery and probe components. Electrical safety compliant with IEC-601. Software-controlled system interface.

Indications for Use

Indicated for diagnostic brain imaging in patients requiring 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.

Related Devices

K964712 — PRISM XPVT SYSTEM (210823) · Philips Medical Systems (Cleveland), Inc. · Feb 21, 1997
K992335 — BEACON-P, MODEL 211059 · Philips Medical Systems (Cleveland), Inc. · Oct 7, 1999
K961577 — PRISM 3000XPV SYSTEM (210714) · Philips Medical Systems (Cleveland), Inc. · Jul 23, 1996
K081757 — VERISTA IMAGING ISOCAM II GAMMA CAMERA · Verista Imaging, Inc. · Aug 15, 2008
K072567 — SYMBIA-E, MODEL 10275879 · Siemens Medical Solutions USA, Inc. · Oct 30, 2007

Submission Summary (Full Text)

{0} K955484 # PICKER INTERNATIONAL 510(k) NOTICE MAR 29 1996 ## XENON OPTION TO THE PRISM 3000 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 Xenon Option. The Xenon Option to the Prism 3000 system is a modification of a gamma camera system. This device is intended to be used for diagnostic brain imaging. There is no change of intended use from that of the predicate device. This device includes a gamma camera system, xenon delivery system, xenon probe, system interface, and the necessary software. Functional specifications and operator’s instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units. The Xenon option to the Prism 3000 system is substantially equivalent to legally marketed devices. The Xenon option will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations. The Xenon option will be certified to electrical safety standards (IEC-601) 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. Clinical tests have shown that the Xenon option is effective in diagnosing brain anomalies. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the Xenon option 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 Xenon option. In addition, all information contained in this 510(k) Notice is accurate and complete.