Company profile

Circle Cardiovascular Imaging, Inc.

Circle Cardiovascular Imaging, Inc. has 7 AI-enabled medical devices on the FDA list. The first decision was on August 22, 2014 and the most recent on October 27, 2025 (cvi42 Coronary Plaque Software Application). Its most common review panel is Radiology (7 devices).

7AI devices

2014First decision

2025Latest decision

1Specialties

Per year

201420212022202320242025

Circle Cardiovascular Imaging, Inc. AI devices per year: 2014 1, 2021 1, 2022 1, 2023 1, 2024 1, 2025 2

By specialty

Radiology7

Related guides

Top radiology devices

Timeline

October 27, 2025 · 510(k) K251027cvi42 Coronary Plaque Software Application · Radiology · QIH
July 1, 2025 · 510(k) K250221StrokeSENS ASPECTS Software Application · Radiology · POK
October 15, 2024 · 510(k) K242781cvi42 Software Application · Radiology · QIH
January 18, 2023 · 510(k) K222593TruPlan Computed Tomography (CT) Imaging Software · Radiology · LLZ
July 28, 2022 · 510(k) K213998cvi42 Auto Imaging Software Application · Radiology · QIH
February 19, 2021 · 510(k) K202212TruPlan · Radiology · LLZ
August 22, 2014 · 510(k) K141480CVI42 · Radiology · LLZ