Cleared Traditional

Xelis Dental 2.0 (K193369) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193369 · Infinitt Healthcare Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
131d
Days
Class 2
Risk

K193369 is an FDA 510(k) clearance for the Xelis Dental 2.0. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Infinitt Healthcare Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on April 14, 2020 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Infinitt Healthcare Co., Ltd. devices

Submission Details

510(k) Number K193369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2019
Decision Date April 14, 2020
Days to Decision 131 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
24d slower than avg
Panel avg: 107d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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

O Tech, Inc.
Carl Alletto

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 - LLZ System, Image Processing, Radiological

All 797
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K193369.
Optimized Positioning System (OPS) Insight
K192656 · Corin USA · May 2020
ArthrexVIP Web Portal
K193523 · Arthrex, Inc. · Apr 2020
NemoFAB
K192475 · Software Nemotec S.L. · Apr 2020
JiveX
K200703 · Visus Health IT GmbH · Apr 2020
VARO Plan
K200078 · 3D Industrial Imaging Co., Ltd. · Apr 2020
EchoNavigator
K200713 · Philips Medical Systems Nederland B.V. · Apr 2020