DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Irom Imaging, Inc.
Product code
Code IZL
Device class
Class 2
Regulation
21 CFR 892.1720
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Englewood, CO, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IZL

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Adverse events under product code IZL

product code IZL
Other
3
Total
3

Source: openFDA MAUDE database, through . 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.