# K072567: Symbia-E, Model 10275879

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 30, 2007 after 48 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K952674 (1995). 18 ancestors in all.
85 later devices descend from it; 2 cite it directly.
7 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963983: E. Cam Profile Attenuation Correction, Siemens Corp. (1997) Summary page 1.
- K041166: Siemens Enhanced Imaging System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K063826: Syngo MI Applications 2007A, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K031825: C.CAM, Danish Diagnostic Development A/S (2003) Summary page 1.
- K051460: C.Cam-AC, Danish Diagnostic Development A/S (2005) Summary page 1.

## Most influential descendants
- 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
- K180815: MIM - SPECTRA Quant (2018), 54 descendants of its own

## Recalls of this device
- May 15, 2012 · Not classified · Z-1686-2012: Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance t
- Apr 11, 2012 · Class II · Z-1296-2015: Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

## Indications for use
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

Source page: https://510kreport.com/device/K072567
Methodology: https://510kreport.com/methodology