The following data is part of a premarket notification filed by Circle Cardiovascular Imaging Inc with the FDA for Cvi42 Auto Imaging Software Application.
| Device ID | K213998 |
| 510k Number | K213998 |
| Device Name: | Cvi42 Auto Imaging Software Application |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Circle Cardiovascular Imaging Inc Suite 1100 - 800 5th Ave SW Calgary, CA T2P 3T6 |
| Contact | Sydney Toutant |
| Correspondent | Sydney Toutant Circle Cardiovascular Imaging Inc Suite 1100 - 800 5th Ave SW Calgary, CA T2P 3T6 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-21 |
| Decision Date | 2022-07-28 |