Cleared Traditional

K010304 - MXR-2000 MOBILE X-RAY UNIT

K010304 is an FDA 510(k) clearance for MXR-2000 MOBILE X-RAY UNIT, manufactured by Irom Imaging, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K010304 · Irom Imaging, Inc. · Radiology device
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Feb 2001
Decision
11d
Days
Class 2
Risk

K010304 is an FDA 510(k) clearance for the MXR-2000 MOBILE X-RAY UNIT. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Irom Imaging, Inc. (Englewood, US). The FDA issued a Cleared decision on February 12, 2001 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Irom Imaging, Inc. devices

FDA 510(k) Submission Details - K010304

510(k) Number K010304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2001
Decision Date February 12, 2001
Days to Decision 11 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 107d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZL System, X-ray, Mobile

All 168
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