Cleared Traditional

K031802 - CORIX 70 PLUS-USV

K031802 is an FDA 510(k) clearance for CORIX 70 PLUS-USV, manufactured by Coramex, S.A.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K031802 · Coramex, S.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
40d
Days
Class 2
Risk

K031802 is an FDA 510(k) clearance for the CORIX 70 PLUS-USV. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Coramex, S.A. (Wheeling, US). The FDA issued a Cleared decision on July 21, 2003 after a review of 40 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 Coramex, S.A. devices

FDA 510(k) Submission Details - K031802

510(k) Number K031802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2003
Decision Date July 21, 2003
Days to Decision 40 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
67d faster than avg
Panel avg: 107d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

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 124
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K031802.
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