Cleared Special

K161117 - EzDent-i / E2 / Prora View

K161117 is the FDA 510(k) clearance for EzDent-i / E2 / Prora View by Ewoosoft Co., Ltd.. It is a Class 2 Radiology device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 Peers - LLZ System, Image Processing, Radiological

All 1057
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K161117.
Senolris
K160937 · Ge Healthcare · Aug 2016
SIMPLANT Online Case Review and SIMPLANT Editor
K161118 · Dentsply Sirona · Jul 2016
Multi Modality Viewer
K161419 · Vital Images, Inc. · Jul 2016
DICOM Viewer
K153653 · Brainlab AG · Apr 2016
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
K160579 · Rayence Co., Ltd. · Apr 2016
Xeleris 4.0 Processing and Review Workstation
K153355 · Ge Healthcare · Mar 2016