# K131634: Symbia

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 16, 2013 after 73 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
Longest line of descent: 7 generations back to K952674 (1995). 20 ancestors in all.
66 later devices descend from it; 1 cites it directly.
1 of 87 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082506: Symbia, Version 4.0, Siemens Medical Solutions USA, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K191928: AccuContour (2020), 30 descendants of its own

## Recalls of this device
- Aug 12, 2014 · Class II · Z-0913-2015: Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.
- Aug 12, 2014 · Class II · Z-0911-2015: Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.
- Aug 12, 2014 · Class II · Z-0912-2015: Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.
- 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
- Apr 23, 2014 · Class II · Z-2042-2014: Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.
- Apr 23, 2014 · Class II · Z-2043-2014: Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.

## 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: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles. SPECT+CT: The SPECT and CT components used together acquire SPECT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images. Software: The syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities.

Source page: https://510kreport.com/device/K131634
Methodology: https://510kreport.com/methodology