Cleared Traditional

K242591 - XERO-alpha

K242591 is the FDA 510(k) clearance for XERO-alpha by DRTECH Corporation. It is a Class 2 Radiology device (product code EHD) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K242591 · DRTECH Corporation · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2024
Decision
63d
Days
Class 2
Risk

K242591 is an FDA 510(k) clearance for the XERO-alpha. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by DRTECH Corporation (Jungwon-Gu, Seongnam-Si, KR). The FDA issued a Cleared decision on November 1, 2024 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 DRTECH Corporation devices

Submission Details

510(k) Number K242591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2024
Decision Date November 01, 2024
Days to Decision 63 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
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 65
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