Cleared Traditional

K151087 - CS 8100SC

K151087 is the FDA 510(k) clearance for CS 8100SC by Trophy. It is a Class 2 Radiology device (product code MUH) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K151087 · Trophy · Radiology device
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Aug 2015
Decision
120d
Days
Class 2
Risk

K151087 is an FDA 510(k) clearance for the CS 8100SC, CS8100SC Access. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Trophy (Croissy-Beaubourg, FR). The FDA issued a Cleared decision on August 21, 2015 after a review of 120 days - within the typical 510(k) review window.

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 devices

Submission Details

510(k) Number K151087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2015
Decision Date August 21, 2015
Days to Decision 120 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 107d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
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 - MUH System, X-ray, Extraoral Source, Digital

All 72
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K151087.
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K150797 · Rayence Co., Ltd. · May 2015
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio
K143753 · Rayence Co., Ltd. · Mar 2015