Cleared Special

K173878 - PreXion3D Excelsior

K173878 is an FDA 510(k) clearance for PreXion3D Excelsior, manufactured by Prexion Corporation. The device is a Class 2 Radiology device with product code OAS cleared through the Special 510(k) pathway after a 29-day FDA review.

K173878 · Prexion Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
29d
Days
Class 2
Risk

K173878 is an FDA 510(k) clearance for the PreXion3D Excelsior. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Prexion Corporation (Chiyoda-Ku, JP). The FDA issued a Cleared decision on January 19, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Prexion Corporation devices

FDA 510(k) Submission Details - K173878

510(k) Number K173878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2017
Decision Date January 19, 2018
Days to Decision 29 days
Submission Type Special
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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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

All 95
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K173878.
RCT800
K181452 · Ray Co., Ltd. · Jul 2018
Orthopantomograph OP 3D
K180947 · Palodex Group OY · Jun 2018
CS 9600
K181136 · Trophy · May 2018
Veraview X800
K171012 · J. Morita USA, Inc. · Dec 2017
Green16/Green18 (Model: PHT-65LHS)
K170066 · VATECH Co., Ltd. · Jun 2017
PaX-i3D Green Premium (Model: PCT-90LH)
K160882 · VATECH Co., Ltd. · Oct 2016