# K952109: IP500 Nuclear Gamma Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 23, 1995 after 110 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
115 later devices descend from it; 4 cite it directly.
6 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992731: E.Cam Computer (1999), 111 descendants of its own
- K023190: E.Cam Computer / E.Soft Workstation (2002), 104 descendants of its own
- K041166: Siemens Enhanced Imaging System (2004), 87 descendants of its own
- K063826: Syngo MI Applications 2007A (2007), 86 descendants of its own
- K072567: Symbia-E, Model 10275879 (2007), 85 descendants of its own

## Recalls of this device
- Apr 8, 2014 · Class II · Z-0914-2015: There is a potential for patient finger injury on the e.cam systems.
- Oct 28, 2013 · Class II · Z-0116-2015: Reports of loose bolts in the detector support structure of Symbia and e.cam systems.
- May 15, 2012 · Not classified · Z-1687-2012: 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 t
- Apr 11, 2012 · Class II · Z-1297-2015: Radial motor drives replaced during a customer service action were incorrectly assembled backwards.
- Dec 18, 2008 · Not classified · Z-1505-2009: 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.
- Sep 5, 2003 · Not classified · Z-0053-04: The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.
- Feb 10, 2003 · Not classified · Z-0623-03: Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.

Source page: https://510kreport.com/device/K952109
Methodology: https://510kreport.com/methodology