Cleared Traditional

AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR (K122298) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122298 · Ajex Meditech., Ltd. · Radiology device
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Mar 2014
Decision
605d
Days
Class 2
Risk

K122298 is an FDA 510(k) clearance for the AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Ajex Meditech., Ltd. (Plainview, US). The FDA issued a Cleared decision on March 28, 2014 after a review of 605 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Ajex Meditech., Ltd. devices

Submission Details

510(k) Number K122298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2012
Decision Date March 28, 2014
Days to Decision 605 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
498d slower than avg
Panel avg: 107d · This submission: 605d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 93
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