Cleared Traditional

K171012 - Veraview X800

K171012 is an FDA 510(k) clearance for Veraview X800, manufactured by J. Morita USA, Inc.. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K171012 · J. Morita USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
259d
Days
Class 2
Risk

K171012 is an FDA 510(k) clearance for the Veraview X800. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on December 19, 2017 after a review of 259 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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

FDA 510(k) Submission Details - K171012

510(k) Number K171012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2017
Decision Date December 19, 2017
Days to Decision 259 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
152d slower than avg
Panel avg: 107d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
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 Consultant

Fish & Richardson, P.C.
Keith A. Barritt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OAS X-ray, Tomography, Computed, Dental

All 126
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K171012.
Orthopantomograph OP 3D
K180947 · Palodex Group OY · Jun 2018
CS 9600
K181136 · Trophy · May 2018
PreXion3D Excelsior
K173878 · Prexion Corporation · Jan 2018
Orthopantomograph OP300
K163423 · Palodex Group OY · Aug 2017
Green16/Green18 (Model: PHT-65LHS)
K170066 · VATECH Co., Ltd. · Jun 2017
ORTHOPANTOMOGRAPH OP 3D
K170813 · Palodex Group OY · Apr 2017