# K050297: Somatom Emotion 16

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solution, Inc. USA
- Decided: Mar 1, 2005 after 22 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023687 (2002). 1 ancestor in all.
34 later devices descend from it; 4 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023687: Somatom Emotion 6 CT Systems, Siemens Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K113287: Somatom Perspective (2012), 30 descendants of its own
- K140912: Somatom Scope/Somatom Scope Power (2014), 29 descendants of its own
- K133590: Somatom Perspective (2014), 29 descendants of its own
- K142955: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power (2015), 27 descendants of its own
- K161196: SOMATOM Drive (2016), 24 descendants of its own

## Recalls of this device
- Feb 15, 2018 · Class II · Z-1454-2018: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on 
- Feb 15, 2018 · Class II · Z-1459-2018: To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on 
- Feb 15, 2018 · Class II · Z-1452-2018: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on 
- Feb 15, 2018 · Class II · Z-1453-2018: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on 
- Feb 15, 2016 · Class II · Z-1301-2016: Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with th
- Mar 21, 2014 · Class II · Z-1721-2014: The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.
- Aug 5, 2008 · Not classified · Z-2453-2008: Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does ha
- Mar 9, 2006 · Not classified · Z-0793-06: When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

## Indications for use
The Siemens SOMATOM Emotion 16 system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Source page: https://510kreport.com/device/K050297
Methodology: https://510kreport.com/methodology