Cleared Traditional

K213998 - cvi42 Auto Imaging Software Application
(FDA 510(k) Clearance)

K213998 · Circle Cardiovascular Imaging, Inc. · Radiology
Jul 2022
Decision
219d
Days
Class 2
Risk

K213998 is an FDA 510(k) clearance for the cvi42 Auto Imaging 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 July 28, 2022, 219 days after receiving the submission on December 21, 2021.

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 K213998 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2021
Decision Date July 28, 2022
Days to Decision 219 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.