Cleared Traditional

K103659 - CS 9300

K103659 is the FDA 510(k) clearance for CS 9300 by Trophy. It is a Class 2 Radiology device (product code OAS) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K103659 · Trophy · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2011
Decision
246d
Days
Class 2
Risk

K103659 is an FDA 510(k) clearance for the CS 9300, CS 9300C. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Trophy (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on August 18, 2011 after a review of 246 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 devices

Submission Details

510(k) Number K103659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2010
Decision Date August 18, 2011
Days to Decision 246 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 107d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
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 - OAS X-ray, Tomography, Computed, Dental

All 90
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K103659.
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PAX-DUO3D PLUS, PCT-5000
K121236 · VATECH Co., Ltd. · May 2012
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102196 · VATECH Co., Ltd. · Mar 2011
ORTHOPHOS XG 3D / CEPH
K103711 · Sirona Dental Systems GmbH · Mar 2011
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
K090467 · VATECH Co., Ltd. · Jan 2010