APX-24 Portable X-ray System— 510(k) K220678

Substantially Equivalent

Aspenstate, Inc.

FDA 510(k) clearance K220678 for APX-24 Portable X-ray System, Substantially Equivalent on 2022-03-31. Applicant: Aspenstate, Inc..

Clearance details

Applicant: Aspenstate, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2022-03-08
Decision date: 2022-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

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.