Cleared Traditional

K232661 - Myocardial Strain Software Application (FDA 510(k) Clearance)

K232661 · Circle Cardiovascular Imaging · Radiology device

Dec 2023

Decision

98d

Days

Class 2

Risk

K232661 is an FDA 510(k) clearance for the Myocardial Strain Software Application. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Circle Cardiovascular Imaging (Calgary, CA). The FDA issued a Cleared decision on December 7, 2023, 98 days after receiving the submission on August 31, 2023.

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

Submission Details

510(k) Number	K232661 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 31, 2023
Decision Date	December 07, 2023
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF