# K241295: SOMATOM On.site

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 3, 2024 after 118 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: 16 generations back to K013561 (2001). 123 ancestors in all.
No later device cites it as a predicate yet.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193277: SOMATOM On.site and On.scene, Siemens Medical Solutions USA, Inc. (2020) Summary page 6.
- K233650: SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed, Siemens Medical Solutions USA, Inc. (2024) Summary page 6.

## Indications for use
This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck. The images delivered by the system can be used by a trained staff as an aid in diagnosis.

Source page: https://510kreport.com/device/K241295
Methodology: https://510kreport.com/methodology