Cleared Traditional

K222145 - EzDent-i / E2 / Prora View/ Smart M Viewer

K222145 is an FDA 510(k) clearance for EzDent-i / E2 / Prora View/ Smart M Viewer, manufactured by Ewoosoft Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K222145 · Ewoosoft Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
23d
Days
Class 2
Risk

K222145 is an FDA 510(k) clearance for the EzDent-i / E2 / Prora View/ Smart M Viewer. 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 August 12, 2022 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. 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 Ewoosoft Co., Ltd. devices

FDA 510(k) Submission Details - K222145

510(k) Number K222145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2022
Decision Date August 12, 2022
Days to Decision 23 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
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1188
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K222145.
WebCeph
K220903 · Assemblecircle Corp. · Aug 2022
syngo Application Software (VE21)
K220433 · Siemens Medical Solution USA, Inc. · Aug 2022
TeraRecon Neuro
K220349 · Terarecon,Inc. · Aug 2022
Dolphin Imaging 12.0
K222072 · Patterson Dental Supply, Inc. · Aug 2022
Neurophet SCALE PET
K221405 · Neurophet., Inc. · Aug 2022
FX SPS
K213922 · Pixee Medical · Jul 2022