Cleared Traditional

K912696 - TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL (FDA 510(k) Clearance)

Class I Radiology device.

K912696 · Bennett X-Ray Corp. · Radiology device
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Sep 1991
Decision
90d
Days
Class 1
Risk

K912696 is an FDA 510(k) clearance for the TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Bennett X-Ray Corp. (Copiague, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1770 - 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 Bennett X-Ray Corp. devices

Submission Details

510(k) Number K912696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date September 16, 1991
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYB Tube Mount, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.