Phase Conjugate Symmetry Option for Outlook
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K960294 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Phase Conjugate Symmetry (PCS) Option is a software option for the Outlook system that reduces magnetic resonance imaging acquisition time by approximately 40% without impacting resolution. It is classified as a System, Nuclear Magnetic Resonance Imaging device and is intended for use in radiology applications.
This device is supplied as a software option for the Outlook system and maintains the same safety specifications for static magnetic field, time varying magnetic field, SAR levels and acoustic noise. It is a Class 2 device that received FDA 510(k) clearance with K number K960294 on 1996-04-19, and is regulated under 892.1000.
Frequently asked questions
What is the Phase Conjugate Symmetry Option for Outlook used for?
The Phase Conjugate Symmetry (PCS) Option is a software option for the Outlook system designed to reduce magnetic resonance imaging acquisition time by approximately 40% without impacting resolution. It is intended for use in radiology applications.
How is the Phase Conjugate Symmetry Option supplied and what are its safety specifications?
This device is supplied as a software option for the Outlook system and maintains the same safety specifications for static magnetic field, time varying magnetic field, SAR levels and acoustic noise as the base system.
What is the regulatory classification and clearance status of this device?
The Phase Conjugate Symmetry Option is classified as a Class 2 device and received FDA 510(k) clearance with K number K960294 on April 19, 1996. It is regulated under 892.1000 and was determined to be substantially equivalent to predicate devices.
Is the Phase Conjugate Symmetry Option a single-use or reusable device?
As a software option for the Outlook system, the Phase Conjugate Symmetry Option is not a physical device that would be classified as single-use or reusable. It is a software enhancement that can be installed and used on the compatible system according to the manufacturer's guidelines.
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: Phase Conjugate Symmetry Option for Outlook, fda.innolitics.com, PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK 510(k) K960294 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K960294 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (1)
- FDA 510(k) K960294 24 fields · synced Oct 6, 2026