# K190505: Low Dose Lung Screening Option

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Jun 5, 2019 after 96 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: 2 generations back to K093891 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121553: Aquilion RXL, Toshibamedical Systems Corporation (2012) Summary page 4.

## Indications for use
The Low Dose CT Lung Cancer Screening Option for Canon/Toshiba CT systems is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society and/or Canon. Information from professional societies related to lung cancer screening can be found, but is not limited to: American College of Radiology® (ACR) — resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) — Lung Cancer Screening Protocols; radiation management.

Source page: https://510kreport.com/device/K190505
Methodology: https://510kreport.com/methodology