7 devices · 4 companies · 2014 to 2025
Circle Cardiovascular Imaging, Inc.: AI-enabled devices on FDA's list
7 devices from Circle Cardiovascular Imaging, Inc., 2014 to 2025, from 4 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Circle Cardiovascular Imaging, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| cvi42 Coronary Plaque Software ApplicationK251027 · 510(k) | Radiology | QIH | database entry | |
| StrokeSENS ASPECTS Software ApplicationK250221 · 510(k) | Radiology | POK | database entry | |
| cvi42 Software ApplicationK242781 · 510(k) | Radiology | QIH | database entry | |
| TruPlan Computed TomographyK222593 · 510(k) | Radiology | LLZ | database entry | |
| cvi42 Auto Imaging Software ApplicationK213998 · 510(k) | Radiology | QIH | database entry | |
| TruPlanK202212 · 510(k) | Radiology | LLZ | database entry | |
| CVI42K141480 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.