Nanox Cart X-ray System— 510(k) K203782

Substantially Equivalent

Nano-X Imaging , Ltd.

FDA 510(k) clearance K203782 for Nanox Cart X-ray System, Substantially Equivalent on 2021-04-01. Applicant: Nano-X Imaging , Ltd..

Clearance details

Applicant: Nano-X Imaging , Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2020-12-28
Decision date: 2021-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neve Ilan, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.