# K253520: Photonova Spectra, Photonova Spectra Select

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Mar 20, 2026 after 128 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: 10 generations back to K013561 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213715: Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition, Ge Medical Systems, LLC (2021) Summary page 5.

## Indications for use
The Photonova Spectra, Photonova Spectra Select system is a silicon-based spectral photon counting detector X-ray Computed Tomography scanner. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system acquires multi-energy data in every scan and natively generates high resolution monochromatic images and material density maps to facilitate visualizing and analyzing information about anatomical and pathological structures. The system is indicated for head, whole body, cardiac, and vascular CT applications. The system is indicated for patients of all ages. The images can be post-processed to produce additional imaging planes or analysis results. The system is indicated for lung cancer screening for patients meeting the established inclusion criteria of programs/protocols that have been published by either a governmental body or professional medical society.* * 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/K253520
Methodology: https://510kreport.com/methodology