# K162337: Symbia 6.5

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 8, 2016 after 17 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K952674 (1995). 22 ancestors in all.
8 later devices descend from it; 1 cites it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142006: Symbia 6.0, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.

## Most influential descendants
- K200474: Symbia 6.7 (2020), 7 descendants of its own
- K210557: Symbia VA10A Family (2021), 4 descendants of its own
- K212604: Symbia VA10A Family (2021), 3 descendants of its own
- K231102: Symbia Pro.specta VA20A Family (2023), 2 descendants of its own
- K243186: Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family (2024), 1 descendant of its own

## Recalls of this device
- Oct 5, 2018 · Class II · Z-0372-2019: The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
- Nov 7, 2017 · Class II · Z-0094-2018: The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification optio
- Nov 7, 2017 · Class II · Z-0093-2018: The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification optio
- Sep 18, 2017 · Class II · Z-0047-2018: The torque wrench used to tighten system bolts during installation was found to be out of tolerance

## 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/K162337
Methodology: https://510kreport.com/methodology