> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 4DMedical Lung Imaging Tool Cleared
- URL: https://www.fdaweb.com/4dmedical-lung-imaging-tool-cleared/
- Published: 2020-05-27T12:00:00.000Z
- Updated: 2026-09-14T16:16:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146867

FDA has cleared a 4DMedical 510(k) for its XV Technology, a patented four-dimensional lung imaging process that is intended to rapidly and automatically analyze any functional lung impairment from a single X-ray. “It provides critical information about the functional and structural state of a patient’s lungs in the treatment of illnesses such as Covid-19, asthma, chronic obstructive pulmonary disease, cystic fibrosis and lung cancer,” the company says. The process uses proprietary algorithms to identify and quantify any functional impairment, and a ventilation report is then generated and sent to the hospital to enable clinicians to determine the most effective treatment. Total time to acquire a diagnostic report is about three hours.

4DMedical describes the device as a software-as-a-service (SaaS) diagnostic tool, which is available through a secure cloud subscription. It is not intended to replace molecular tests as the primary diagnosis method for Covid-19, but instead it provides quantitative support for diagnosis and follow-up examinations for patients with, or recovering from Covid-19.