Cleared Traditional

K233247 - Heuron ICH (FDA 510(k) Clearance)

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

K233247 · Heuron Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
230d
Days
Class 2
Risk

K233247 is an FDA 510(k) clearance for the Heuron ICH. Classified as Radiological Computer-assisted Triage And Notification Software (product code QAS), Class II - Special Controls.

Submitted by Heuron Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on May 15, 2024 after a review of 230 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2080 - 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 Heuron Co., Ltd. devices

Submission Details

510(k) Number K233247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date May 15, 2024
Days to Decision 230 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
123d slower than avg
Panel avg: 107d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAS Radiological Computer-assisted Triage And Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2080
Definition Radiological Computer-assisted Triage And Notification Software Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification .
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

Hogan Lovells US LLP
John J. Smith

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 - QAS Radiological Computer-assisted Triage And Notification Software

All 83
Devices cleared under the same product code (QAS) and FDA review panel - the closest regulatory comparables to K233247.
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
K253163 · Ever Fortune.Ai, Co., Ltd. · Apr 2026
JLK-NCCT
K252421 · JLK, Inc. · Mar 2026
Annalise Enterprise
K253818 · Harrison-AI Medical Pty, Ltd. · Mar 2026
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax
K253578 · Aidoc Medical , Ltd. · Feb 2026
BriefCase-Triage
K251195 · Aidoc Medical , Ltd. · Jan 2026
BriefCase-Triage: CARE Multi-triage CT Body
K252970 · Aidoc Medical , Ltd. · Jan 2026