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Gyroscan Acs-Nt, Gyroscan T5-Nt and Gyroscan T10-Nt

by Philips Medical Systems North America, Inc.

510(k) K945945

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK945945 Date22 Dec 1995ClearedStatusActive

Recalls

5 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1439-2018 FDA Class II initiated 16 Mar 2018
    • Terminated Z-1440-2018 FDA Class II initiated 16 Mar 2018
    • Terminated Z-1438-2018 FDA Class II initiated 16 Mar 2018

    Potential risk for helium gas inside the MR examination room during a magnet quench

    • Terminated Z-1024-2016 FDA Class II initiated 6 Jul 2015

    Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.

    • Terminated Z-0981-2007 FDA Unclassified (pre-2012) initiated 30 Apr 2007

    Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

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  • Withdrawn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

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