# K023687: Somatom Emotion 6 CT Systems

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Nov 22, 2002 after 21 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
130 later devices descend from it; 6 cite it directly.
6 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Siemens SOMATOM Emotion Duo: named in the summary without a submission number
- (no number) Somatom Sensation 4 CT scanners: named in the summary without a submission number

## Most influential descendants
- K041166: Siemens Enhanced Imaging System (2004), 87 descendants of its own
- K063826: Syngo MI Applications 2007A (2007), 86 descendants of its own
- 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

## Recalls of this device
- Feb 1, 2018 · Class II · Z-2472-2018: A potential risk of unnecessary radiation exposure due to a software issue
- Feb 1, 2018 · Class II · Z-2473-2018: A potential risk of unnecessary radiation exposure due to a software issue
- Feb 15, 2016 · Class II · Z-1300-2016: 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-2452-2008: 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
- Sep 28, 2004 · Not classified · Z-0157-05: Calcium Scoring feature on this devices is not closing properly after patient's exams.

## Indications for use
The SOMATOM Emotion 6 systems are 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/K023687
Methodology: https://510kreport.com/methodology