Cleared Traditional

AVIEW (K214036) - FDA 510(k) Clearance

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

K214036 · Coreline Soft Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
365d
Days
Class 2
Risk

K214036 is an FDA 510(k) clearance for the AVIEW. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Coreline Soft Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 23, 2022 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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-to-high 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 K214036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2021
Decision Date December 23, 2022
Days to Decision 365 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
258d slower than avg
Panel avg: 107d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
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 - QIH Automated Radiological Image Processing Software

All 297
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K214036.
LVivo IQS
K222970 · Dia Imaging Analysis, Ltd. · Feb 2023
Rapid RV/LV
K223396 · Ischemaview, Inc. · Feb 2023
Clarius AI
K222406 · Clarius Mobile Health Corp. · Jan 2023
Saige-Density
K222275 · DeepHealth, Inc. · Dec 2022
BrainInsight
K223268 · Hyperfine, Inc. · Dec 2022
SIS System (Version 5.6.0)
K223032 · Surgical Information Sciences, Inc. · Nov 2022