Cleared Traditional

K851095 - INTRAORAL DENTAL X-RAY SYSTEM 70-X

K851095 is an FDA 510(k) clearance for INTRAORAL DENTAL X-RAY SYSTEM 70-X, manufactured by Trophy Radiologie. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K851095 · Trophy Radiologie · Radiology device
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Sep 1985
Decision
168d
Days
Class 2
Risk

K851095 is an FDA 510(k) clearance for the INTRAORAL DENTAL X-RAY SYSTEM 70-X. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Trophy Radiologie (Vincennes, Cedex (Paris), FR). The FDA issued a Cleared decision on September 3, 1985 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 - K851095

510(k) Number K851095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1985
Decision Date September 03, 1985
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 95
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K851095.
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