Cleared Traditional

K242015 - TOPAZ Mobile X-ray System (Models : TOP...

K242015 is an FDA 510(k) clearance for TOPAZ Mobile X-ray System (Models : TOP..., manufactured by DRGEM Corporation. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K242015 · DRGEM Corporation · Radiology device
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Dec 2024
Decision
159d
Days
Class 2
Risk

K242015 is an FDA 510(k) clearance for the TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D). Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by DRGEM Corporation (Gwangmyeong-Si, KR). The FDA issued a Cleared decision on December 16, 2024 after a review of 159 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all DRGEM Corporation devices

FDA 510(k) Submission Details - K242015

510(k) Number K242015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2024
Decision Date December 16, 2024
Days to Decision 159 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 107d · This submission: 159d
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 130
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