Cleared Traditional

K162085 - i-CAT FLX V series / KaVo 3D eXam+ V series

K162085 is an FDA 510(k) clearance for i-CAT FLX V series / KaVo 3D eXam+ V series, manufactured by Imaging Sciences International. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K162085 · Imaging Sciences International · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
106d
Days
Class 2
Risk

K162085 is an FDA 510(k) clearance for the i-CAT FLX V series / KaVo 3D eXam+ V series. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Imaging Sciences International (Hatfield, US). The FDA issued a Cleared decision on November 10, 2016 after a review of 106 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K162085

510(k) Number K162085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2016
Decision Date November 10, 2016
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
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 134
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K162085.
ORTHOPANTOMOGRAPH OP 3D
K170813 · Palodex Group OY · Apr 2017
HYPERION X5
K161900 · Cefla S.C. · Dec 2016
X-MIND trium
K160166 · De Gotzen S.R.L. · Nov 2016
PaX-i3D Green Premium (Model: PCT-90LH)
K160882 · VATECH Co., Ltd. · Oct 2016
Green Smart (Model: PHT-35LHS)
K162660 · VATECH Co., Ltd. · Oct 2016
PreXion3D Excelsior
K161881 · Prexion Corporation · Oct 2016