Cleared Special

K161117 - EzDent-i / E2 / Prora View

K161117 is an FDA 510(k) clearance for EzDent-i / E2 / Prora View, manufactured by Ewoosoft Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 23-day FDA review.

K161117 · Ewoosoft Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
23d
Days
Class 2
Risk

K161117 is an FDA 510(k) clearance for the EzDent-i / E2 / Prora View. 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 Ewoosoft Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on May 13, 2016 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Low regulatory complexity profile. 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 Ewoosoft Co., Ltd. devices

FDA 510(k) Submission Details - K161117

510(k) Number K161117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2016
Decision Date May 13, 2016
Days to Decision 23 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
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

LLZ Device Classification - Class 2, Special Controls

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

LK Consulting Group USA, Inc.
PRISCILLA CHUNG

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 1764
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K161117.
HEPATIQ 1.1
K161188 · Hepatiq, LLC · Jun 2016
Ez3D-i / E3
K161246 · Ewoosoft Co., Ltd. · May 2016
3mensio Workstation
K153736 · Pie Medical Imaging BV · May 2016
MIM-Thin Client (mobile)
K151913 · Mim Software, Inc. · Apr 2016
sterEOS Workstation
K160914 · Eos Imaging, Inc. · Apr 2016
DICOM Viewer
K153653 · Brainlab AG · Apr 2016