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Philips Gyroscan T5 II Release 3

FDA 510(k)

Class II (US FDA 510(k))

510(k) K930708

by Philips Medical Systems, Inc.

Identifiers

510(k) Number
K930708 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 Philips Gyroscan T5 II Release 3 is a magnetic resonance imaging (MRI) system that uses strong magnetic fields and radio waves to produce high-resolution images of the body's internal structures. It is classified as a Class II device under product code LNH and is intended for diagnostic imaging in clinical settings.

The system is supplied by Philips Medical Systems, Inc. and was authorized under FDA 510(k) clearance K930708, with a decision date of January 25, 1994. It is regulated under regulation number 892.1000 and falls within the Radiology specialty. The device is designed for professional use in medical imaging environments and is subject to standard MRI safety considerations.

Frequently asked questions

What is the Philips Gyroscan T5 II Release 3 used for?

The Philips Gyroscan T5 II Release 3 is a magnetic resonance imaging (MRI) system designed for diagnostic imaging in clinical settings, producing high-resolution images of the body's internal structures.

How is the Philips Gyroscan T5 II Release 3 supplied?

The system is supplied by Philips Medical Systems, Inc. and is intended for professional use in medical imaging environments.

What is the regulatory status of the Philips Gyroscan T5 II Release 3?

The device was authorized under FDA 510(k) clearance K930708 with a decision date of January 25, 1994, and is classified as a Class II device under product code LNH.

What safety considerations should be taken into account with this MRI system?

The device is subject to standard MRI safety considerations, which include precautions related to strong magnetic fields and radio waves used in the imaging process.

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: PHILIPS GYROSCAN T5 II RELEASE 3 - fda.innolitics.com, Philips Gyroscan T5 Ii Release 3 510 (k) K930708 - FDA.report, Philips Gyroscan T5 II Release 3 - Philips Medical Systems | FDA Reference, PDF K930708 - PHILIPS GYROSCAN T5 II RELEASE 3 - 510kdatabase.net

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K930708 24 fields · synced Sep 19, 2026