ACU-RAY— 510(k) K931279

Substantially Equivalent

Sterne Equipment Co., Ltd.

FDA 510(k) clearance K931279 for ACU-RAY, Substantially Equivalent on 1993-11-03. Applicant: Sterne Equipment Co., Ltd..

Clearance details

Applicant: Sterne Equipment Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 1993-03-08
Decision date: 1993-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brampton, On., CA

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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.