# K193277: SOMATOM On.site and On.scene

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 22, 2020 after 238 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: 13 generations back to K013561 (2001). 118 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051765: Ceretom, Model NL3000, Neurologica Corporation (2005) Summary page 5.
- K192061: SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO, Siemens Medical Solutions USA, Inc. (2019) Summary page 5.
- K111912: Mobilett Mira, Siemens Medical Solutions USA, Inc. (2011) Summary page 5.

## Most influential descendants
- K241295: SOMATOM On.site (2024), 0 descendants of its own

## Indications for use
This computed tomography system is intended to generate and process cross-sectional images by computer reconstruction of x-ray transmission data within a 25 cm field-of-view, primarily for the head and neck. The images delivered by SOMATOM On.site and On.scene can be used by a trained physician as an aid in diagnosis.

Source page: https://510kreport.com/device/K193277
Methodology: https://510kreport.com/methodology