Cleared Traditional

K953936 - ATLANTIS

K953936 is an FDA 510(k) clearance for ATLANTIS, 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 129-day FDA review.

K953936 · Trophy Radiologie · Radiology device
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Dec 1995
Decision
129d
Days
Class 2
Risk

K953936 is an FDA 510(k) clearance for the ATLANTIS. 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 December 28, 1995 after a review of 129 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.

View all Trophy Radiologie devices

FDA 510(k) Submission Details - K953936

510(k) Number K953936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1995
Decision Date December 28, 1995
Days to Decision 129 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
22d slower than avg
Panel avg: 107d · This submission: 129d
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 7
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K953936.
ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM
K960028 · Dentsply Intl. · Mar 1996
TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
K950533 · Trophy Radiologie · Jun 1995
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · Trophy Radiologie · Apr 1995
PORTARAY
K792535 · Siemens Corp. · Jan 1980
RAFLEX 70
K792437 · Mdt Corp., Inc. · Jan 1980
GE-700 INTRA ORAL X-RAY SYSTEM
K781630 · General Electric Co. · Dec 1978