Cleared Traditional

K931486 - INTREX VSK INTERORAL DENTAL X-RAY UNIT (FDA 510(k) Clearance)

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

K931486 · Keystone X-Ray, Inc. · Radiology device
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Nov 1993
Decision
244d
Days
Class 2
Risk

K931486 is an FDA 510(k) clearance for the INTREX VSK INTERORAL DENTAL X-RAY UNIT. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Keystone X-Ray, Inc. (Neptune Township, US). The FDA issued a Cleared decision on November 23, 1993 after a review of 244 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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 Keystone X-Ray, Inc. devices

Submission Details

510(k) Number K931486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1993
Decision Date November 23, 1993
Days to Decision 244 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
137d slower than avg
Panel avg: 107d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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.