Cleared Traditional

K131442 - FIRECR DENTALIMAGING SYSTEM

K131442 is an FDA 510(k) clearance for FIRECR DENTALIMAGING SYSTEM, manufactured by 3Disc Americas. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K131442 · 3Disc Americas · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
109d
Days
Class 2
Risk

K131442 is an FDA 510(k) clearance for the FIRECR DENTALIMAGING SYSTEM. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by 3Disc Americas (Naples, US). The FDA issued a Cleared decision on September 6, 2013 after a review of 109 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 3Disc Americas devices

FDA 510(k) Submission Details - K131442

510(k) Number K131442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date September 06, 2013
Days to Decision 109 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
2d slower than avg
Panel avg: 107d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K131442.
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K141700 · Genoray Co., Ltd. · Oct 2014
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K130419 · Genoray Co., Ltd. · Nov 2013
RAYSCAN A-EXPERT
K131693 · Ray Co., Ltd. · Nov 2013
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
K130088 · Genoray Co., Ltd. · Jul 2013
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K130585 · VATECH Co., Ltd. · Jul 2013
RAYSCAN A-EXPERT
K122918 · Ray Co., Ltd. · Mar 2013