# K151749: somatom Scope (with syngo CT VC30-easyIQ version), SOMATOM Scope Power (with syngo CT VC30-easyIQ version)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 18, 2016 after 263 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: 7 generations back to K982349 (1998). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140912: Somatom Scope/Somatom Scope Power, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.
- K143401: SOMATOM Definition Edge, Siemens Medical Solutions USA, Inc. (2015) Summary page 5.

## Recalls of this device
- Nov 22, 2016 · Class II · Z-0919-2017: Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM
- Nov 22, 2016 · Class II · Z-0920-2017: Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM

## Indications for use
The SOMATOM Scope 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 xray tube, and the simultaneous translation of the patient.)

Source page: https://510kreport.com/device/K151749
Methodology: https://510kreport.com/methodology