# K180901: Low Dose CT Lung Cancer Screening Option

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Healthcare Americas
- Decided: May 16, 2018 after 40 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: 6 generations back to K930090 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153444: Philips Multislice CT System with Low Dose CT Lung Cancer, Philips Medical Systems (Cleveland), Inc. (2016) Summary page 4.

## Indications for use
The Low Dose CT Lung Cancer Screening Option for the SCENARIA and SUPRIA 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 Hitachi. Some examples of published articles can be found at the American College of Radiology® (ACR) website: * ACR-SCBT-MR-SPR Practice Parameter for the Performance of Thoracic Computed Tomography (CT) Res. 10 —2013 * ACR-STR Practice Parameter for the Performance and Reporting of Lung Cancer Screening Thoracic Computed Tomography (CT) Res. 4 — 2014 * Lung Cancer Screening Technical Specifications * Lung Cancer Screening Resources In addition, examples of published articles can be found at the American Association of Physicists Medicine (AAPM) website: » Lung Cancer Screening CT Protocols Version 4.0, 02/23/16 * AAPM Report No. 96: The Measurement, Reporting, and Management of Radiation Dose in CT

Source page: https://510kreport.com/device/K180901
Methodology: https://510kreport.com/methodology