OSTEO-RAY 100— 510(k) K953404

Substantially Equivalent

Micro Focus Imaging, Inc.

FDA 510(k) clearance K953404 for OSTEO-RAY 100, Substantially Equivalent on 1995-11-30. Applicant: Micro Focus Imaging, Inc..

Clearance details

Applicant: Micro Focus Imaging, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 1995-07-20
Decision date: 1995-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, 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.