# K100619: Symbia.Net, Symbia.Net Select Model 10520828, 10520827

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 7, 2010 after 64 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K952674 (1995). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 28 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 2.
- K072205: Visage Pacs/CS, Release Version 5.0, Mercury Computer Systems, Inc. (2007) Summary page 2.

## Most influential descendants
- K110844: Symbia.Net (2011), 0 descendants of its own

## 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. 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/K100619
Methodology: https://510kreport.com/methodology