cvi42 Coronary Plaque Software Application
FDA 510(k) K251027 · Circle Cardiovascular Imaging, Inc.
510(k) numberK251027
Submission
- Device name
- cvi42 Coronary Plaque Software Application
- Applicant
- Circle Cardiovascular Imaging, Inc.
Calgary, CA - Received
- April 2, 2025
- Decision date
- October 27, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
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.
Other 510(k)s with product code QIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
More from Lucida Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K250221 | StrokeSENS ASPECTS Software ApplicationPOK · Traditional | 07/01/2025SE |
| K242781 | cvi42 Software ApplicationQIH · Special | 10/15/2024SE |
| K241038 | Cardiac CT Function Software ApplicationQIH · Traditional | 06/07/2024SE |
| K232661 | Myocardial Strain Software ApplicationLLZ · Traditional | 12/07/2023SE |
| K222593 | TruPlan Computed Tomography (CT) Imaging SoftwareLLZ · Traditional | 01/18/2023SE |
| K213998 | cvi42 Auto Imaging Software ApplicationQIH · Traditional | 07/28/2022SE |
| K202212 | TruPlanLLZ · Traditional | 02/19/2021SE |
| K141480 | CVI42LLZ · Traditional | 08/22/2014SE |
| K111373 | CT42 Cardiac Computed Tomography (CT) SoftwareLLZ · Traditional | 08/23/2011SE |
| K082628 | CMR42 Cardiac MRI Imaging System, 2.1.23LLZ · Traditional | 11/20/2008SE |
Questions and answers
When was cvi42 Coronary Plaque Software Application cleared by the FDA?
cvi42 Coronary Plaque Software Application (K251027) received a 510(k) decision of Substantially Equivalent on October 27, 2025, 208 days after the submission was received.
What is the product code of K251027?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.