# K142006: Symbia 6.0

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 21, 2014 after 29 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: 8 generations back to K952674 (1995). 21 ancestors in all.
65 later devices descend from it; 2 cite 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)
- K131634: Symbia, Siemens Medical Solutions USA, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- K190379: MIM on Linux (2019), 14 descendants of its own

## Recalls of this device
- Aug 5, 2016 · Class II · Z-2758-2016: "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instructions for 
- Mar 31, 2016 · Class II · Z-2898-2020: E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurrence is rem
- Feb 26, 2016 · Class II · Z-1263-2016: We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbi
- Feb 26, 2016 · Class II · Z-1262-2016: We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbi
- Dec 31, 2015 · Class II · Z-0687-2016: To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.
- Jul 31, 2015 · Class II · Z-2437-2015: Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller asse
- Jul 31, 2015 · Class II · Z-2435-2015: Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller asse
- Jul 31, 2015 · Class II · Z-2436-2015: Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller asse
- Jun 26, 2015 · Class II · Z-0208-2016: Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a 

## 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 take at different angles. SPECT+CT: The SPECT and CT components used together acquire SPECT/CT 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/K142006
Methodology: https://510kreport.com/methodology