Cleared Traditional

K073365 - DENTAL DIGITAL X-RAY IMAGING SYSTEM

K073365 is an FDA 510(k) clearance for DENTAL DIGITAL X-RAY IMAGING SYSTEM, manufactured by VATECH Co., Ltd.. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K073365 · VATECH Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
130d
Days
Class 2
Risk

K073365 is an FDA 510(k) clearance for the DENTAL DIGITAL X-RAY IMAGING SYSTEM. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by VATECH Co., Ltd. (Sound Beach, US). The FDA issued a Cleared decision on April 8, 2008 after a review of 130 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 VATECH Co., Ltd. devices

FDA 510(k) Submission Details - K073365

510(k) Number K073365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2007
Decision Date April 08, 2008
Days to Decision 130 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 107d · This submission: 130d
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 89
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K073365.
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K092171 · Genoray Co., Ltd. · Apr 2010
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
K100317 · VATECH Co., Ltd. · Mar 2010
XIOS PLUS WALL-MODULE
K081903 · Sirona Dental Systems GmbH · Aug 2008
VERAVIEWEPOCS
K073696 · J. Morita USA, Inc. · Apr 2008
PLANMECA PROONE
K072244 · Planmeca Oy · Sep 2007
GALILEOS
K060892 · Sirona Dental Systems GmbH · Apr 2006