Cleared Traditional

AVIEW CAC

K233211 · Coreline Soft Co., Ltd. · Radiology
Mar 2024
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K233211 is an FDA 510(k) clearance for the AVIEW CAC, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Coreline Soft Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on March 29, 2024, 183 days after receiving the submission on September 28, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K233211 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2023
Decision Date March 29, 2024
Days to Decision 183 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — 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.