K251027 is an FDA 510(k) clearance for the cvi42 Coronary Plaque 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 October 27, 2025, 208 days after receiving the submission on April 2, 2025.
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..
| 510(k) Number | K251027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2025 |
| Decision Date | October 27, 2025 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| 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. |