# K082506: Symbia, Version 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 21, 2008 after 84 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K952674 (1995). 19 ancestors in all.
83 later devices descend from it; 4 cite it directly.
7 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041166: Siemens Enhanced Imaging System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K072567: Symbia-E, Model 10275879, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K063826: Syngo MI Applications 2007A, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K952109: IP500 Nuclear Gamma Camera System, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K131634: Symbia (2013), 66 descendants of its own
- K142006: Symbia 6.0 (2014), 65 descendants of its own
- K162483: Symbia Intevo Bold (2017), 63 descendants of its own
- K180815: MIM - SPECTRA Quant (2018), 54 descendants of its own
- K182624: MIM - MRT Dosimetry (2018), 53 descendants of its own

## Recalls of this device
- Jul 28, 2014 · Class II · Z-2713-2014: Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is sit
- Jul 28, 2014 · Class II · Z-2712-2014: Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is sit
- Mar 5, 2014 · Class II · Z-0960-2015: There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.
- Oct 28, 2013 · Class II · Z-0115-2015: Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.
- Aug 16, 2013 · Class II · Z-0062-2017: 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-1087-2015: There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
- Oct 14, 2011 · Not classified · Z-0283-2012: Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue
- Oct 14, 2011 · Not classified · Z-0284-2012: Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue
- Jun 22, 2011 · Not classified · Z-2980-2011: There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orb

## Indications for use
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. 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 plane taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

Source page: https://510kreport.com/device/K082506
Methodology: https://510kreport.com/methodology