Cleared Traditional

K881133 - 70-X/RVG (RADIOVISIOGRAPHY) (FDA 510(k) Clearance)

Class I Radiology device.

K881133 · Trophy Radiologie · Radiology device
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Jul 1989
Decision
491d
Days
Class 1
Risk

K881133 is an FDA 510(k) clearance for the 70-X/RVG (RADIOVISIOGRAPHY). Classified as Bar, Preformed (product code EHO), Class I - General Controls.

Submitted by Trophy Radiologie (Vincennes, Cedex (Paris), FR). The FDA issued a Cleared decision on July 20, 1989 after a review of 491 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.3165 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Trophy Radiologie devices

Submission Details

510(k) Number K881133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1988
Decision Date July 20, 1989
Days to Decision 491 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
384d slower than avg
Panel avg: 107d · This submission: 491d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHO Bar, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3165
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.