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Gyroview Hr High Resolution Workstation

by Philips Medical Systems North America, Inc.

510(k) K896647

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK896647 Date21 Dec 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Gyroview Hr High Resolution Workstation is a System, Nuclear Magnetic Resonance Imaging device. It is designed to assist in imaging procedures.

The device is supplied by Philips Medical Systems North America, Inc. and has been cleared via the FDA 510(k) pathway. It is classified as a Class II device under product code LNH.

Other devices from Philips Medical Systems North America, Inc.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Gyroview HR High Resolution Workstation used for?

    The Gyroview HR High Resolution Workstation is used to assist in imaging procedures, specifically in Nuclear Magnetic Resonance Imaging.

  • How is the device supplied?

    The device is supplied by Philips Medical Systems North America, Inc.

  • What is the regulatory classification of the Gyroview HR High Resolution Workstation?

    The device is classified as a Class II device under product code LNH.