MXR-2000 MOBILE X-RAY UNIT— 510(k) K010304

Substantially Equivalent

Irom Imaging, Inc.

FDA 510(k) clearance K010304 for MXR-2000 MOBILE X-RAY UNIT, Substantially Equivalent on 2001-02-12. Applicant: Irom Imaging, Inc..

Clearance details

Applicant: Irom Imaging, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2001-02-01
Decision date: 2001-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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.