MINXRAY, MODEL HF100H+— 510(k) K052721

Substantially Equivalent

Minxray, Inc.

FDA 510(k) clearance K052721 for MINXRAY, MODEL HF100H+, Substantially Equivalent on 2005-10-27. Applicant: Minxray, Inc..

Clearance details

Applicant: Minxray, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2005-09-29
Decision date: 2005-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Deer Field, IL, US

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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.