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Gyroscan T5 Magnetic Resonance Diagnostic Device

by Philips Medical Systems North America, Inc.

510(k) K890789

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK890789 Date28 Apr 1989ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1442-2018 FDA Class II initiated 16 Mar 2018

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

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  • Withdrawn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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