Cleared Traditional

K925094 - VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS

K925094 is an FDA 510(k) clearance for VISUALIX RADIOGRAPHIC IMAGE DETECTING A..., manufactured by Gendex Corp.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K925094 · Gendex Corp. · Radiology device
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Sep 1993
Decision
357d
Days
Class 2
Risk

K925094 is an FDA 510(k) clearance for the VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Gendex Corp. (Des Plaines, US). The FDA issued a Cleared decision on September 29, 1993 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Gendex Corp. devices

FDA 510(k) Submission Details - K925094

510(k) Number K925094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1992
Decision Date September 29, 1993
Days to Decision 357 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
250d slower than avg
Panel avg: 107d · This submission: 357d
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 149
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