# K063826: Syngo MI Applications 2007A

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 12, 2007 after 17 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: 4 generations back to K952674 (1995). 11 ancestors in all.
86 later devices descend from it; 2 cite it directly.
7 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992731: E.Cam Computer, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K023190: E.Cam Computer / E.Soft Workstation, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K041166: Siemens Enhanced Imaging System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K072567: Symbia-E, Model 10275879 (2007), 85 descendants of its own
- K082506: Symbia, Version 4.0 (2008), 83 descendants of its own
- 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

## Indications for use
Syngo Ml Applications 2007A is a software product intended for use with nuclear medicine applications. It 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. It is used to detect or image the distribution of radionuclides in the body or organ(s) using the following techniques: * planar imaging and processing whole body imaging * tomographic imaging positron imaging by coincidence positron imaging without coincidence up to 588 keV display, process and fusion of nuclear medicine, SPECT, PET, CT and hybrid images.

Source page: https://510kreport.com/device/K063826
Methodology: https://510kreport.com/methodology