Cleared Traditional

AVIEW LCS (K193220) - FDA 510(k) Clearance

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

K193220 · Coreline Soft Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
166d
Days
Class 2
Risk

K193220 is an FDA 510(k) clearance for the AVIEW LCS. 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 Coreline Soft Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on May 5, 2020 after a review of 166 days - an extended review 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 Coreline Soft Co., Ltd. devices

Submission Details

510(k) Number K193220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2019
Decision Date May 05, 2020
Days to Decision 166 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
59d slower than avg
Panel avg: 107d · This submission: 166d
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 Peers - LLZ System, Image Processing, Radiological

All 789
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K193220.
Brainomix 360 e-CTA
K192692 · Brainomix Limited · May 2020
CariCloud
K200274 · Caristo Diagnostics · May 2020
syngo Ultrasound Apps Suite (sUSAS)
K201062 · Siemens Medical Solutions USA, Inc. · May 2020
Ziostation2
K200315 · Ziosoft, Inc. · May 2020
ZeeroMED View
K200546 · O3 Enterprise Srl · May 2020
Optimized Positioning System (OPS) Insight
K192656 · Corin USA · May 2020