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IP500 Nuclear Gamma Camera System

by Siemens Medical Solutions USA, Inc.

510(k) K952109

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 NumberK952109 Date23 Aug 1995ClearedStatusActive

Recalls

7 recalls · FDA

    • Terminated Z-0914-2015 FDA Class II initiated 8 Apr 2014

    There is a potential for patient finger injury on the e.cam systems.

    • Terminated Z-0116-2015 FDA Class II initiated 28 Oct 2013

    Reports of loose bolts in the detector support structure of Symbia and e.cam systems.

    • Terminated Z-1687-2012 FDA Not yet classified initiated 15 May 2012

    Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. If the gear is installed incorrectly the mechanical brake may not engage creating a patient hazard if the sys

    • Terminated Z-1297-2015 FDA Class II initiated 11 Apr 2012

    Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

    • Terminated Z-1505-2009 FDA Unclassified (pre-2012) initiated 18 Dec 2008

    Patient fingers can get pinched if they attempt to pull themselves up from the patient handling system without any assistance and grabbing onto the flip-up FOV indicator bars.

    • Terminated Z-0053-04 FDA Unclassified (pre-2012) initiated 5 Sep 2003 on shared 510(k) K952109

    The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.

    • Terminated Z-0623-03 FDA Unclassified (pre-2012) initiated 10 Feb 2003

    Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.

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

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  • Withdrawn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
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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