HealthFLD— 510(k) K233080

Substantially Equivalent

Nano-X AI , Ltd.

FDA 510(k) clearance K233080 for HealthFLD, Substantially Equivalent on 2024-02-08. Applicant: Nano-X AI , Ltd..

Clearance details

Applicant: Nano-X AI , Ltd.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2023-09-26
Decision date: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sefayim, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.