# K251061: NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 28, 2025 after 115 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K013561 (2001). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243523: NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime, Siemens Medical Solutions USA, Inc. (2025) Summary page 6.

## Recalls of this device
- Dec 19, 2025 · Class II · Z-1240-2026: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- Dec 19, 2025 · Class II · Z-1241-2026: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- Dec 19, 2025 · Class II · Z-1242-2026: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

## Indications for use
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*. * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Source page: https://510kreport.com/device/K251061
Methodology: https://510kreport.com/methodology