Cleared Traditional

K945682 - PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (FDA 510(k) Clearance)

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

K945682 · Gendex Corp. · Radiology device
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Feb 1995
Decision
80d
Days
Class 2
Risk

K945682 is an FDA 510(k) clearance for the PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL. Classified as Processor, Radiographic-film, Automatic, Dental (product code EGY), Class II - Special Controls.

Submitted by Gendex Corp. (Des Plaines, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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 Gendex Corp. devices

Submission Details

510(k) Number K945682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date February 09, 1995
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EGY Processor, Radiographic-film, Automatic, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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.