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Magnetom Espree System

by Siemens Medical Solutions USA, Inc.

510(k) K041112

Magnetom Espree System is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K041112 on 21 Jul 2004, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041112 Date21 Jul 2004ClearedStatusActive

Official records

Recalls

4 recalls · FDA

    • Terminated Z-2021-2011 FDA Unclassified (pre-2012) initiated 3 Mar 2011

    Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.

    • Terminated Z-0518-2008 FDA Unclassified (pre-2012) initiated 5 Nov 2007

    Table may experience a deadlock situation

    • Terminated Z-0769-2007 FDA Unclassified (pre-2012) initiated 30 Mar 2007

    If table top is not seated properly it can lock up/stick.

    • Terminated Z-1529-05 FDA Unclassified (pre-2012) initiated 12 Aug 2005 on shared 510(k) K041112

    there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K041112
  2. Recall initiated FDA recalls Z-1529-05
  3. Recall initiated FDA recalls Z-0769-2007
  4. Recall initiated FDA recalls Z-0518-2008
  5. Recall initiated FDA recalls Z-2021-2011

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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging).

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