AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR— 510(k) K122298

Substantially Equivalent

Ajex Meditech., Ltd.

FDA 510(k) clearance K122298 for AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR, Substantially Equivalent on 2014-03-28. Applicant: Ajex Meditech., Ltd..

Clearance details

Applicant: Ajex Meditech., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2012-07-31
Decision date: 2014-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainview, NY, 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.