PX-100 PORTABLE X-RAY GENERATOR— 510(k) K921116

Substantially Equivalent

Acoma Medical Imaging, Inc.

FDA 510(k) clearance K921116 for PX-100 PORTABLE X-RAY GENERATOR, Substantially Equivalent on 1992-10-05. Applicant: Acoma Medical Imaging, Inc..

Clearance details

Applicant: Acoma Medical Imaging, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 1992-03-09
Decision date: 1992-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, IL, 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.