The following data is part of a premarket notification filed by Circle Cardiovascular Imaging Inc with the FDA for Cvi42.
| Device ID | K141480 |
| 510k Number | K141480 |
| Device Name: | CVI42 |
| Classification | System, Image Processing, Radiological |
| Applicant | CIRCLE CARDIOVASCULAR IMAGING INC Suite 250, 815 8th Avenue SW Calgary, CA T2p 3p2 |
| Contact | Shirantha Samarappuli |
| Correspondent | Shirantha Samarappuli CIRCLE CARDIOVASCULAR IMAGING INC Suite 250, 815 8th Avenue SW Calgary, CA T2p 3p2 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-04 |
| Decision Date | 2014-08-22 |
| Summary: | summary |