# K991600: Somatom Plus 4 with Sliding Gantry Option

- Pathway: 510(k) (Special)
- Applicant: Siemens Corp.
- Decided: Jun 9, 1999 after 30 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941546 (1994). 2 ancestors in all.
32 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990491: Angio-CT Miyabi, Siemens Medical Solutions USA, Inc. (1999) Summary page 2.
- K941546: Somatom Project 059, Siemens Corp. (1994) Summary page 2.

## Most influential descendants
- K051765: Ceretom, Model NL3000 (2005), 27 descendants of its own
- K090811: Inspira HD, Model: NL1000 (2009), 10 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K171183: OmniTom (2017), 6 descendants of its own
- K061834: Xcat; Xcat for Neuro (2006), 6 descendants of its own

## Indications for use
The SOMATOM Plus 4 with Sliding Gantry Option 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 angels 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 movement of the sliding gantry.)

Source page: https://510kreport.com/device/K991600
Methodology: https://510kreport.com/methodology