Cleared Special

K242781 - cvi42 Software Application
(FDA 510(k) Clearance)

K242781 · Circle Cardiovascular Imaging, Inc. · Radiology
Oct 2024
Decision
29d
Days
Class 2
Risk

K242781 is an FDA 510(k) clearance for the cvi42 Software Application. This device is classified as a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH).

Submitted by Circle Cardiovascular Imaging, Inc. (Calgary, CA). The FDA issued a Cleared decision on October 15, 2024, 29 days after receiving the submission on September 16, 2024.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. 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..

Submission Details

510(k) Number K242781 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2024
Decision Date October 15, 2024
Days to Decision 29 days
Submission Type Special
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.