Identifiers
- 510(k) Number
- K955484 FDA 510(k)
- FDA Product Code
- KPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xenon Option to Prism 3000 is a modification of a gamma camera system intended for diagnostic brain imaging. This device is designed to be operated by trained healthcare professionals responsible for Nuclear Medicine diagnostic examinations.
The device is manufactured by Philips Medical Systems (Cleveland), Inc. and received FDA 510(k) clearance with K955484 on March 29, 1996. It is classified as a System, Tomography, Computed, Emission with device class 2 and product code KPS. The device is substantially equivalent to legally marketed devices and is intended for use in Radiology.
Frequently asked questions
What is the Xenon Option to Prism 3000 used for?
The Xenon Option to Prism 3000 is a modification of a gamma camera system specifically designed for diagnostic brain imaging. It is intended to be operated by trained healthcare professionals responsible for Nuclear Medicine diagnostic examinations.
How is the Xenon Option to Prism 3000 supplied?
The device is manufactured by Philips Medical Systems (Cleveland), Inc. and is supplied as a modification to existing Prism 3000 gamma camera systems. It is designed to be integrated into the existing system for enhanced diagnostic capabilities.
What is the regulatory status of the Xenon Option to Prism 3000?
The device received FDA 510(k) clearance with K955484 on March 29, 1996. It is classified as a System, Tomography, Computed, Emission with device class 2 and product code KPS, and is substantially equivalent to legally marketed devices.
Is the Xenon Option to Prism 3000 reusable or single-use?
The device is a modification to an existing gamma camera system and is designed for repeated use in clinical settings. It is not a single-use device and should be maintained according to the manufacturer's specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: XENON OPTION TO PRISM 3000 (K955484) — FDA 510(k) | Innolitics, XENON OPTION TO PRISM 3000 (K955484) - FDA 510 (k), fda.innolitics.com, Assembly Technology for SMART DEVICES » XENON Automation, PDF K955484 - XENON OPTION TO PRISM 3000 - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K955484 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (1)
- FDA 510(k) K955484 24 fields · synced Oct 6, 2026