ACU-RAY HF SERIES PORTABLE X-RAY UNIT— 510(k) K972204

Substantially Equivalent

Sterne Equipment Co., Ltd.

FDA 510(k) clearance K972204 for ACU-RAY HF SERIES PORTABLE X-RAY UNIT, Substantially Equivalent on 1997-10-08. Applicant: Sterne Equipment Co., Ltd..

Clearance details

Applicant: Sterne Equipment Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 1997-06-12
Decision date: 1997-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brampton, On., CA

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.