Cleared Traditional

K170813 - ORTHOPANTOMOGRAPH OP 3D

K170813 is an FDA 510(k) clearance for ORTHOPANTOMOGRAPH OP 3D, manufactured by Palodex Group OY. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K170813 · Palodex Group OY · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
21d
Days
Class 2
Risk

K170813 is an FDA 510(k) clearance for the ORTHOPANTOMOGRAPH OP 3D. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Palodex Group OY (Tuusula, FI). The FDA issued a Cleared decision on April 7, 2017 after a review of 21 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Palodex Group OY devices

FDA 510(k) Submission Details - K170813

510(k) Number K170813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2017
Decision Date April 07, 2017
Days to Decision 21 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
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 Peers - OAS X-ray, Tomography, Computed, Dental

All 96
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K170813.
PreXion3D Excelsior
K173878 · Prexion Corporation · Jan 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
Green Smart (Model: PHT-35LHS)
K162660 · VATECH Co., Ltd. · Oct 2016
RCT700
K160525 · Ray Co., Ltd. · Jun 2016