# K041166: Siemens Enhanced Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 17, 2004 after 13 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952674 (1995). 8 ancestors in all.
87 later devices descend from it; 3 cite it directly.
7 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992731: E.Cam Computer, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K952109: IP500 Nuclear Gamma Camera System, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.
- K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera, Ge Medical Systems F.I. Haifa (1999) Summary page 1.
- K023687: Somatom Emotion 6 CT Systems, Siemens Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K063826: Syngo MI Applications 2007A (2007), 86 descendants of its own
- K072567: Symbia-E, Model 10275879 (2007), 85 descendants of its own
- K082506: Symbia, Version 4.0 (2008), 83 descendants of its own
- K131634: Symbia (2013), 66 descendants of its own
- K142006: Symbia 6.0 (2014), 65 descendants of its own

## Recalls of this device
- Aug 16, 2013 · Class II · Z-0061-2017: The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allow
- Oct 23, 2012 · Class II · Z-1086-2015: There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
- Dec 11, 2009 · Not classified · Z-0584-2010: Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.
- Dec 11, 2009 · Not classified · Z-0583-2010: Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.
- Apr 22, 2009 · Not classified · Z-1676-2009: The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.
- Apr 22, 2009 · Not classified · Z-1677-2009: The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.
- Mar 11, 2009 · Not classified · Z-1649-2009: Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detec
- Mar 11, 2009 · Not classified · Z-1648-2009: Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detec
- Sep 29, 2008 · Not classified · Z-0190-2009: The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard.
- Sep 29, 2008 · Not classified · Z-0189-2009: The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard.
- Jan 30, 2007 · Not classified · Z-0549-2007: Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
- Jan 30, 2007 · Not classified · Z-0548-2007: Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.

## Indications for use
SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

Source page: https://510kreport.com/device/K041166
Methodology: https://510kreport.com/methodology