# K140912: Somatom Scope/Somatom Scope Power

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 15, 2014 after 159 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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: 3 generations back to K940606 (1994). 8 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050297: Somatom Emotion 16, Siemens Medical Solution, Inc. USA (2005) Summary page 5.
- K042328: Somatom Spirit, Siemens Medical Systems, Inc. (2004) Summary page 5.

## Most influential descendants
- 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
- K162302: Somatom Confidence ® RT Pro (2016), 21 descendants of its own
- K173630: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence (2018), 20 descendants of its own
- K190578: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence (2019), 19 descendants of its own

## Recalls of this device
- Feb 1, 2018 · Class II · Z-2476-2018: A potential risk of unnecessary radiation exposure due to a software issue
- Feb 1, 2018 · Class II · Z-2477-2018: A potential risk of unnecessary radiation exposure due to a software issue

## Indications for use
The SOMATOM Scope and SOMATOM Scope Power 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/K140912
Methodology: https://510kreport.com/methodology