Cleared Traditional

K962337 - ELITYS OR ELITYS-E

K962337 is an FDA 510(k) clearance for ELITYS OR ELITYS-E, 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 38-day FDA review.

K962337 · Trophy Radiologie · Radiology device
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Jul 1996
Decision
38d
Days
Class 2
Risk

K962337 is an FDA 510(k) clearance for the ELITYS OR ELITYS-E. 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 July 25, 1996 after a review of 38 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Trophy Radiologie devices

FDA 510(k) Submission Details - K962337

510(k) Number K962337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1996
Decision Date July 25, 1996
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
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 94
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K962337.
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
K964659 · Dentsply Intl. · Dec 1996
DIGIPAN
K961826 · Trophy Radiologie · Sep 1996
TOMOGRAPH ACCESSORIES
K962120 · Steri-Oss, Inc. · Jul 1996
PROSTYLE INTRA
K955429 · Planmeca Oy · Dec 1995
PANORAMIC X-RAY UNIT (MODIFICATION)
K952763 · Planmeca Oy · Oct 1995
PANORAMIC X-RAY UNITS, MODIFICATION
K934063 · Planmeca Oy · Dec 1993