Cleared Traditional

K073696 - VERAVIEWEPOCS

K073696 is the FDA 510(k) clearance for VERAVIEWEPOCS by J. Morita USA, Inc.. It is a Class 2 Radiology device (product code MUH) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K073696 · J. Morita USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
99d
Days
Class 2
Risk

K073696 is an FDA 510(k) clearance for the VERAVIEWEPOCS. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on April 8, 2008 after a review of 99 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 J. Morita USA, Inc. devices

Submission Details

510(k) Number K073696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2007
Decision Date April 08, 2008
Days to Decision 99 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
8d faster than avg
Panel avg: 107d · This submission: 99d
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 71
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K073696.
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
DENTAL DIGITAL X-RAY IMAGING SYSTEM
K073365 · VATECH Co., Ltd. · Apr 2008
GALILEOS
K060892 · Sirona Dental Systems GmbH · Apr 2006
KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
K060079 · Eastman Kodak Company · Feb 2006
VERAVIEW IC 5, MODEL XDP1
K053220 · J. Morita USA, Inc. · Jan 2006