Cleared Traditional

K950533 - TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY

K950533 is an FDA 510(k) clearance for TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY, manufactured by Trophy Radiologie. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K950533 · Trophy Radiologie · Radiology device
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Jun 1995
Decision
147d
Days
Class 2
Risk

K950533 is an FDA 510(k) clearance for the TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Trophy Radiologie (Vincennes, Cedex (Paris), FR). The FDA issued a Cleared decision on June 30, 1995 after a review of 147 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K950533

510(k) Number K950533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1995
Decision Date June 30, 1995
Days to Decision 147 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 107d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EAP Unit, X-ray, Intraoral

All 29
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K950533.
ATLANTIS
K953936 · Trophy Radiologie · Dec 1995
EXPLOR-X (AZTEH) HF
K954565 · Chicago X-Ray Systems, Inc. · Oct 1995
LUMIX 70B
K951734 · Emix U.S.A., Inc. · Jul 1995
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · Trophy Radiologie · Apr 1995
AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER
K950667 · Chicago X-Ray Systems, Inc. · Apr 1995
HELIODENT MD
K950030 · Pelton & Crane Co. · Feb 1995
K950533 · TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
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