Cleared Traditional

K120106 - APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM

K120106 is an FDA 510(k) clearance for APIXIA DIGIREX DIGITAL DENTAL REDIOGRAP..., manufactured by Apixia, Inc.. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K120106 · Apixia, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
115d
Days
Class 2
Risk

K120106 is an FDA 510(k) clearance for the APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Apixia, Inc. (Industry, US). The FDA issued a Cleared decision on May 7, 2012 after a review of 115 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 Apixia, Inc. devices

FDA 510(k) Submission Details - K120106

510(k) Number K120106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2012
Decision Date May 07, 2012
Days to Decision 115 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
8d slower than avg
Panel avg: 107d · This submission: 115d
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 99
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K120106.
VANTAGE MODEL V5000, V5100, V5000C, V5100C
K122643 · Midmark Corp. · Jan 2013
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K122155 · VATECH Co., Ltd. · Sep 2012
VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K120263 · Genoray Co., Ltd. · Jul 2012
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K113672 · VATECH Co., Ltd. · Mar 2012
CLEARVISION
K112380 · Midmark Corp. · Nov 2011
CS 7600
K111649 · Carestream Health, Inc. · Sep 2011